Surgical drape with sterile barrier

ABSTRACT

A surgical drape is configured for covering a patient and an ultrasonography probe during surgical treatment of the patient. The surgical drape may include a first portion that includes a canopy portion. The canopy portion can be sized and shaped to at least partially cover a mechanical arm coupled to the ultrasonography probe and a proximal portion of the ultrasonography probe, and the canopy portion can be configured to move with the proximal portion of the ultrasonography probe when the ultrasonography probe is supported by the mechanical arm. A second portion can be coupled to the first portion, in which the second portion is sized and shaped to cover at least a portion of a torso of the patient.

RELATED APPLICATIONS

The present application is a continuation of International ApplicationNo. PCT/US2018/046254, published as WO/2019/032986 on Feb. 14, 2019, andclaims the benefit under 35 U.S.C. § 119(e) of U.S. ProvisionalApplication No. 62/543,893, filed Aug. 10, 2017, and to United StatesProvisional application, filed May 14, 2018, the entire disclosures ofwhich are incorporated herein by reference.

BACKGROUND

Surgical systems and devices have been used in urological procedures onmale patients. For example, in male urological procedures, a transrectalultrasonography (TRUS) probe may be inserted into the rectum of thepatient in conjunction with insertion of a handpiece into the urethra.During the surgical procedure, it is often necessary to cover or drapeboth the devices and the patient to protect them from contamination byblood or other bodily fluids. While surgical drapes are commonly used tocover a patient's body, conventional drapes and systems for providing asterile barrier and for effective fluid management can be less thanideal in at least some respects. For example, conventional drapes formale urological surgical procedures may have a simple, generally flatshape that may not be well suited for use with some surgical systems andtransrectal probes, and as such may impede the mobility of the TRUSprobe or a mechanical arm coupled to the TRUS probe. Moreover,conventional drapes may be opaque and may not permit visibility of thesurgical site while allowing freedom of movement of the TRUS probe.Also, prior surgical drapes can allow greater accumulation of surgicalfluids than would be ideal in at least some instances. In somesituations, the drape may sag due to the weight of a filled fluid bagattached thereto. Additionally, removal of the drape may be moredifficult than would be ideal, for example after the urology procedurewith surgical instruments (e.g. catheters) still in place or with acatheter securing or tensioning device placed on the patient.

In light of the above, it would be desirable to provide a drape thatallows for improved ease of use with surgical instruments while reducinginterference or impedance in the operation and movement of an imagingprobe. Moreover, it would be desirable to provide surgical drapes havingimproved fluid management capability and that serve as a substantiallytransparent sterile barrier between the urethra and rectum during aurology procedure.

SUMMARY

Some embodiments of the present invention comprise an improved steriledrape system, and methods for draping or covering portions of a surgicalsystem and a patient. The system, apparatus, and methods disclosedherein relate to a drape for protecting the patient and surgical systemduring urology procedures. Advantageously, some embodiments of thepresent invention allow a surgical system to be protected by a drapethat provides improved visibility and monitoring of instruments insertedinto surgical site while reducing interference or impedance in theoperation and movement of an imaging probe of the surgical system. Theembodiments disclosed herein can be advantageous in providing improvedfluid management and provide decreased accumulation of fluids duringurological surgical procedures.

A surgical drape may comprise a canopy portion configured for placementover a proximal portion of a transrectal device, in which the canopyportion comprises a canopy sized and shaped to receive the proximalportion of the transrectal device. The canopy portion may comprise abarrier material configured to allow manipulation of the proximalportion of the transrectal device through the canopy portion whilemaintaining a sterile surgical field above the transrectal device. Thecanopy portion may comprise a protrusion, such as a rectangular orcurved protrusion on an upper sterile side, so as to define anunderlying volume on a lower non-sterile side, sized and shaped toreceive the proximal portion of the transrectal device. The canopyportion may comprise shaping elements to add stiffness to the canopy andallow the user to at least partially shape the canopy as desired tofacilitate use of the canopy.

The surgical drape may comprise a torso portion sized and shaped tocover at least a portion of the torso of the patient. The drape maycomprise an opening sized and shaped to allow surgical access to theurethra of the patient, in which the opening is located between thetorso portion and the canopy portion and may correspond to a pelvicportion of the patient, although the opening can be located on the torsoportion or the canopy portion or a pelvic portion of the drape extendingbetween the canopy portion and the torso portion. The canopy portion canbe configured to move with the proximal portion of the transrectaldevice while the opening remains in a fixed location on the patient.

The surgical drape may comprise a container portion connected to thecanopy portion and the torso portion, in which the container portion isconfigured to collect and release fluids that drain from the canopyportion and optionally the torso portion. The canopy portion maycomprise concave inverted portions near the protrusion, in order todirect fluid from the opening and the canopy portion toward thecontainer portion. The container portion may comprise a porous structureupstream of a suction port, in which the porous structure compriseschannels sized to inhibit passage of blood clots and tissue from thepatient that could clog the suction port, and to pass surgical fluidssuch as saline and blood plasma to the suction port. The containerportion may comprise stiffening elements to maintain the containerportion in an open configuration. Each of the torso portion, the canopyportion, and the container portion may comprise flexible sheet material,such that the drape may comprise a compact sterile configuration forstorage prior to use and an extended configuration when placed on thepatient.

In one aspect, a surgical drape for covering a patient and a transrectaldevice during a surgical treatment of the patient is provided. In someembodiments, the drape comprises a canopy portion sized and shaped to atleast partially cover a proximal portion of the transrectal device, thecanopy portion configured to permit the user to manipulate thetransrectal device through the canopy portion, and a torso portioncoupled to the canopy portion, the torso portion sized and shaped tocover at least a portion of a torso of the patient.

In some embodiments, the canopy portion and the torso portion comprise asterile barrier material to maintain sterility between a urethra and arectum of the patient when a sterile urological probe has been insertedinto the urethra of the patient and the transrectal probe has beeninserted into a rectum of the patient. Optionally, the canopy portioncan comprise an optically transmissive sterile barrier material thatpermits viewing of the proximal portion of the transrectal devicethrough the optically transmissive sterile barrier material. Further,the optically transmissive material can comprise one or more of atransparent material, a translucent material, a semi-transparentmaterial, or a semi-translucent material.

In some embodiments, the torso portion comprises an opaque material andoptionally wherein the canopy portion comprises an opaque material.Further, the transrectal device can comprise one or more of atransrectal ultrasonography (TRUS) probe or a colonoscope.

In some embodiments, the first portion of the drape can comprise anopening sized to receive a penis of the patient from a non-sterile sideof the surgical drape so as to extend a portion of the penis to asterile side of the drape and to receive a sterile surgical instrumentto be inserted into a urethra of the patient from the sterile side ofthe drape, and wherein the opening is located in proximity to the canopyportion and optionally wherein the opening is located adjacent to thecanopy portion. Additionally, the drape can further comprise a containerportion comprising sheet material coupled to the canopy portion toreceive surgical fluids, with the container portion comprising a lowerend with a suction port to drain fluids from the container and a porousstructure upstream of the suction port to inhibit clogging of thesuction port. Additionally still, the container portion can comprisestiffeners to maintain the container in an open configuration to receivethe surgical fluids and optionally wherein the stiffeners comprisetransversely extending stiffeners. Alternatively, the canopy portion cancomprise a protruding portion on an upper side of the drape sized andshape to receive the proximal portion of the transrectal device andinverted portions on the upper side of the drape comprising oppositecurvature to facilitate drainage toward the container portion.

In some embodiments, the torso portion, the canopy portion of thecontainer portion comprise a material that is impervious to surgicalfluids. Further, the surgical instrument can comprise one or more of asurgical probe or a diagnostic probe. Even further, the canopy portioncan permit viewing of the transrectal device and maintains sterility ofthe surgical instrument when the surgical instrument is inserted intothe urethra of the patient.

In some embodiments, the canopy portion can be coupled to an opening ina first portion comprising the canopy portion.

In some embodiments, the canopy portion can comprise a three-dimensionalspace sized and shaped to cover the proximal portion of the transrectaldevice such that the proximal portion of the transrectal device ispermitted to move within the three-dimensional space and optionallywherein the transrectal device is configured to move within thethree-dimensional space in a non-restrictive manner. Alternatively, thethree-dimensional space defines a volume within a range from about 750cm³ to about 70,000 cm³. Alternatively still, the three-dimensionalspace can comprise a substantially rectangular shape, a curved shape, orcan be sized and shaped to cover proximal portions of a plurality oftransrectal devices of different sizes and shapes. Even alternativelystill, the canopy portion can comprise a volume that is greater than avolume occupied by the proximal portion of the transrectal device.

In some embodiments, the canopy portion can comprise a material having athickness ranging from about 0.25 mm to about 3 mm. Alternatively, thematerial can be substantially flexible, or the material can besubstantially rigid or non-compliant, or the material can comprise oneor more of polyethylene, polypropylene, or a translucent polymeric film.

In some embodiments, the canopy portion can comprise a full volume in afully extended configuration and is configured to collapse to less thanthe full volume in a free-standing configuration and optionally whereinthe free-standing configuration corresponds to the canopy portion beingsupported along a lower perimeter and being allowed to collapse at leastpartially under its own weight and optionally wherein the full volume ofthe canopy portion corresponds to a volume of the canopy portion whenfilled with a fluid and supported around the perimeter of the canopyportion.

In some embodiments, the canopy portion can be configured to collapse toless than its full volume when the canopy portion is covering theproximal portion of the transrectal device.

In some embodiments, a second portion comprises the torso portioncomprises a weakened material extending along a midline of the secondportion to assist removal of the surgical drape by allowing the secondportion to separate along the weakened material and optionally whereinthe weakened material comprises one or more of perforations, thinnedmaterial relative to adjacent unweakened material, thermally orchemically weakened material or stressed material along the midline.

In some embodiments, a second weakened material extends in a seconddirection transverse to the midline in order to facilitate removal ofthe surgical drape around a base of a traction device coupled to thepatient with a catheter extending along a urethra of the patient andoptionally wherein the second weakened material comprises perforationsextending in the second direction.

In some embodiments, the second portion comprises perforations extendingalong a midline of the second portion to assist removal of the surgicaldrape. Alternatively, the second portion can further comprise a materialdisposed on top and/or below the perforations, wherein said material isimpervious to fluids. Alternatively still, said material can comprise atape covering the perforations from below and/or above the perforations.Even further, the tape can comprise a first tape layer on top of theperforations and a second tape layer below the perforations such thatthe perforations are sandwiched between the first and second tape layersand optionally wherein the perforations allow insertion or access of acatheter to be inserted into a urethra of the patient and optionallywherein the catheter comprises a suprapubic catheter to drain urine froma bladder of the patient. Alternatively, a sliding mechanism can beconfigured to slide along the perforation to open the perforations andoptionally wherein the sliding mechanism comprises a sliding dove-tailmechanism that releasably opens and closes the perforation andoptionally wherein the sliding dove-tail mechanism comprises a zipper.

In some embodiments, a container can be coupled to the torso portion andthe canopy portion to receive fluid from the canopy portion.Alternatively, the canopy portion can comprise an inverted portion todirect surgical fluids toward the container and optionally wherein theinverted portion comprises a concave upper surface to direct surgicalfluids toward the container. Alternatively, the canopy portion can bedesigned such that fluid flows downward toward the container when thecanopy portion is in an inverted configuration. In a furtheralternative, the inverted configuration can prevent the fluid fromaccumulating or pooling on the canopy portion. In a further alternative,the inverted configuration can comprise one or more sloping surfacesthat aid the fluid to flow downward toward the container.

In some embodiments, a container can have an opening and configured toreceive and store waste including bodily fluids, surgical-relatedfluids, tissue or debris generated during the surgical treatment.Alternatively, the container can comprise a material impervious tosurgical fluids and is configured to provide a storage volume within arange from about 1 cm³ to about 70,000 cm³ and optionally within a rangefrom about 1000 cm³ to about 10,000 cm³. Alternatively, the containercan comprise a surgical suction port and a porous structure to inhibitclogging of the suction port of the container, the porous structurecomprising as one or more of a tube with holes on an outer wall, ascreen, a mesh, a fabric, a grating, a plurality of apertures formed ina sheet of material, an open cell foam, a sponge a screen, a perforatedtubing matrix, fabric, a sintered material, or particles held togetherto define channels. Alternatively, the container can comprise anattachment configured to releasably attach the container to an upperpart of the second portion to support the container holding the waste.Alternatively still, the attachment can comprise tethers coupled to theupper part of the second portion from two sides of the opening of thecontainer. Alternatively, the container can comprise a connector at abottom of the container configured to connect to a suction system.Alternatively, the container can comprise a screen attached to a lowerinner side of the container, wherein the waste is passed through thescreen, and wherein the screen is configured to collect the tissue.Alternatively, the container can comprise a third sheet of material thatis separable from a first sheet of material forming the canopy portionand a second sheet forming the torso portion. Alternatively, thecontainer and the canopy portion can be formed from the same sheet ofmaterial.

In some embodiments, the canopy portion and the torso portion can bedetachably coupled to each other.

In some embodiments, a first portion can comprise the canopy portioncomprises a sheet of material comprising joined edges.

In some embodiments, the canopy portion can be integrally formed withthe torso portion from a single piece of material.

In some embodiments, the canopy portion can comprise a separate sheet ofmaterial that is attachable to the torso portion.

In some embodiments, the canopy portion and the torso portion can beformed together as one piece.

In some embodiments, the canopy portion and the torso portion can bejoined together as one piece.

In some embodiments, the canopy portion can be coupled to a cut-outformed in the torso portion.

In some embodiments, one or more of the torso portion, the canopyportion or a container portion can comprise thermoformed material shapedwith a mold to define a shape of the one or more of the torso portion,the canopy portion or the container portion. Alternatively, the canopyportion and the torso portion can be formed from a single sheet ofthermoformed material and optionally wherein the canopy portion has beenthermoformed on a mold to shape the canopy portion to receive thetransrectal device and optionally wherein the canopy portion comprises aconvex outer surface to deflect fluid away from the canopy portion and aconcave inner surface to receive the proximal portion of the transrectaldevice and optionally wherein the canopy portion comprise asubstantially uniform thickness extending between the concave surfaceand the convex surface and optionally wherein the substantially uniformthickness varies by no more than 25%.

In some embodiments, the canopy portion can be configured to allowmanipulation of the transrectal device through the canopy portion andoptionally wherein the canopy portion is configured to permit the userto control the movement of the transrectal device through the canopyportion. Alternatively, the canopy portion can be configured to permitthe user to move the transrectal device by holding and moving theproximal portion of the transrectal device through the canopy portionwith the canopy portion disposed between a hand of the user and thetransrectal device and wherein the canopy portion is configured to movewith the proximal portion. Alternatively still, the canopy portion canbe disposed between the proximal portion of the transrectal device andthe hand of the user is configured to move from a first position to asecond position when the proximal portion of the transrectal devicemoves from a first position to a second position and wherein the canopyportion is configured to return at least partially from the secondposition toward the first position when the hand of the user releasesthe proximal portion and optionally wherein the canopy portion comprisesa volume greater than a volume of the proximal portion of thetransrectal device in order to allow the proximal portion to return fromthe second position toward the first position and optionally wherein adistance of return from the second position toward the first positioncomprises a distance within a range from about 1 mm to about 25 mm.Optionally, a return of the canopy portion toward the first position canallow the user to hold the proximal portion of the transrectal deviceand move the proximal portion of the transrectal device from the secondposition to a third position and optionally wherein the proximal portionof the transrectal device comprises a knob and each of the firstposition, the second position and the third position correspond torotational orientations of the knob.

In some embodiments, the canopy portion can be sized and shaped to atleast partially cover a surgical arm coupled to the transrectal device.

In some embodiments, the canopy portion can be configured to cover atleast a surgical arm coupled to the transrectal device and the proximalportion of the transrectal device such that the canopy portioncollectively moves with the surgical arm and the proximal portion of thetransrectal device. Alternatively, the canopy portion can be configuredto permit the user to manipulate the surgical arm that supports thetransrectal device through the canopy portion. Alternatively still, theproximal portion of the transrectal device can be mounted on thesurgical arm and the canopy portion is configured to cover at least aportion of the surgical arm and the proximal portion of the transrectaldevice when the distal portion of the transrectal device has beeninserted into the patient. In an alternatively embodiment an apparatuscomprising the surgical drape, the transrectal device, and the surgicalarm as detailed in the alternative embodiment can be provided.

In some embodiments, the surgical drape can comprise a volume within arange from about 100 cm³ to about 4,000 cm³ in a compact configurationwhen stored in a compact configuration within a sterile storagecontainer and wherein the canopy portion comprises a volume within arange from about 750 cm³ to about 70,000 cm³ when the surgical drapecomprises an expanded deployed configuration. Alternatively, thecontainer portion can comprise a volume within a range from about 1000cm³ to about 40,000 cm³ in the expanded deployed configuration andoptionally wherein the volume is within a range from about 1000 cm³ toabout 40,000 cm³.

In some embodiments, at least one of a first portion can comprise thecanopy portion or a second portion comprising the torso portion isoperably coupled to an actuation element configured to deploy one ormore sections of the surgical drape from a compact configuration to anextended configuration. Alternatively, the actuation element comprisesone or more spring elements and wherein the one or more spring elementscan comprise spring steel. In one alternative, the surgical drape cancomprise the actuation element. In one alternative, the one or moresections of the surgical drape can comprise the canopy portion. In onealternative, the compact configuration can comprise a substantiallytwo-dimensional shape, and the extended configuration comprises asubstantially three-dimensional shape. In one alternative, the surgicaldrape can be in the compact configuration when the surgical drape is notin use prior to deployment, and deployed to the extended configurationprior to or during use of said surgical drape for the surgical treatmentof the patient.

In some embodiments, the first portion of the surgical drape cancomprise an opening with an adjustable closure to cinch around anexternal organ of the patient comprising a urethra for maintainingintegrity of a sterile field or environment and optionally wherein theorgan comprises a penis of the patient. In one alternative, theadjustable closure can comprise a zipper.

In some embodiments, the first portion of the surgical drape cancomprise an opening with an adhesive material to gather and wrap loosesections of the drape around an organ of the patient for maintainingintegrity of a sterile surgical field or environment.

In some embodiments, a first portion of the surgical drape can comprisematerial for covering a torso or legs of the patient. In onealternative, the material is configured to hang freely. In onealternative, the material is wrapped around the torso or underside ofthe legs of the patient or stirrups. In one alternative, the material issecured using straps, tethers, Velcro™, and/or tape. In one alternative,the material can comprise an adhesive for attaching the material aroundthe stirrups to form a holder in which a container for receiving andstoring waste can be secured and suspended.

In some embodiments, a portion of the drape can be mounted to a supportstructure that is attached to an operating table over or near thepatient. In one alternative, the portion of the drape is mounted to thesupport structure using straps, tethers, Velcro™, and/or tape. In onealternative, the support structure can be attached to the operatingtable using straps, tethers, Velcro™, and/or tape. In one alternative,the support structure can be configured to couple to or comprises agraphical display. In one alternative, the second portion of the drapecan comprise a transparent material that permits the graphical displayto be viewed through the drape. In one alternative, the second portioncan comprise a transparent window comprising said transparent material,that permits viewing of the graphical display through the surgicaldrape. In one alternative, the graphical display comprises atouchscreen. In one alternative, the transparent material can becompatible for use with the touchscreen such that a user is able tointeract with the touchscreen with the transparent material as anintervening layer. In one alternative, the transparent material isflexible or loose-fitting so as to allow a user to manually manipulateone or more input/output (I/O) devices that are connected to thegraphical display. In one alternative, the one or more I/O devices cancomprise one or more of a joystick, mouse, trackball, trackpad, or3-dimension cursor.

In some embodiments, the container can comprise a substantially conicalfunnel shape to allow fluids to drain to an exit port.

In some embodiments, the container can comprise a substantiallyrectangular funnel shape to allow fluids to drain to an exit port.

In some embodiments, the container can comprise structures forsupporting one or more configurations of the container. In onealternative, the structures can comprise inclined pleats, substantiallyvertical pleats or substantially horizontal pleats. In one alternative,the inclined or vertical pleats serve as stiffeners that prevent thecontainer from collapsing and changing its shape/form under load. In onealternative, the vertical pleats can be configured to allow air flow tovent displaced fluid as the fluid is being extracted or drained from thecontainer. In one alternative, the substantially horizontal pleats cancomprise curved pleats configured to permit the container to collapseinto a collapsed configuration in a telescoping manner. In onealternative, the container is collapsible to a substantially planarconfiguration, and extendable to a substantially 3-dimensionalconfiguration with aid of the substantially horizontal pleats.

In some embodiments, the container comprises a flexible, semi-rigid, orrigid material.

In some embodiments, the container can be configured to serve as apackaging enclosure for storing the surgical drape or portion thereof.In one alternative, the packaging enclosure is used to store thesurgical drape or portion thereof when the surgical drape can be in itsoriginal state prior to use. In one alternative, the packaging enclosurecan be to store the surgical drape or portion thereof for subsequentdisposal after the surgical drape has been used.

In some embodiments, the container can be attachable to a user's gownusing attachment means comprising of mechanical couplings or adhesivetape.

In some embodiments, the container can be coupled to a halter structurethat is configured to be worn on or around a neck of a user.

In some embodiments, the container can comprise one or more compliantstiffening elements for maintaining structural form of the container.

In some embodiments, at least one of the first portion or the secondportion can comprise one or more frame structures that support aconfiguration of at least the first portion or the second portion.

In some embodiments, the container can comprise an integral perforatedtubing matrix to maintain fluid flow and air displacement and optionallywherein the perforated tubing matrix comprises stiffness to maintain thecontainer in an expanded profile configuration. In one alternative, theperforated tubing matrix is connected to a drain/suction port. In onealternative, the perforated tubing matrix comprises one or more fluidicchannels. In one alternative, the one or more fluidic channels extendsfor a length of about 5 cm to about 40 cm along a plurality of surfacesof the drape under a filter screen.

In some embodiments, the container can be designed to ensure sufficientsuction of fluid from the container by (1) providing non block-ablepassageways for the suction to act on the fluid, or (2) by providing amechanism that prevents material from folding over a vacuum port andblocking the vacuum port.

In some embodiments, the container can comprise rolled up tube-likeareas formed from rolled up drape material, wherein said rolled uptube-like areas are connected to a drain/suction port to maintain fluidflow and air displacement.

In some embodiments, the container can comprise a deployable flap thatis positioned to prevent fluid splash onto a user. In one alternative,the deployable flap can comprise a non-sterile portion that extendsoutside of the surgical drape. In one alternative, the deployable flapcan comprise a self-supporting semi-cylindrical shape or form. In onealternative, the deployable flap can comprise stiffening structures thatare adjustable in position.

In some embodiments, the container can comprise one or more ports foraccepting fluid from an irrigation or aspiration pump, or from a drainline above or below a screen.

In some embodiments, the one or more ports can comprise an opening, anaperture, a fenestration, a connecting feature, or a sealing flange.

In some embodiments, the container can comprise one or more extrudedportions extending from the container. In one alternative, the one ormore extruded portions can comprise an inner sterile surface and anexternal non-sterile surface. In one alternative, the externalnon-sterile surfaces provide a working space for placement of a supportstructure comprising the surgical arm. In one alternative, the externalnon-sterile surfaces allow ungloved hand(s) to access a sterile spacedefined within the inner sterile surfaces for manipulation of thetransrectal device.

In some embodiments, the container can comprise a screen. In onealternative, the screen can be coupled to an inner lower portion of thecontainer. In one alternative, the screen can be detachable forcollecting and transporting tissue or solid samples for analysis ordisposal. In one alternative, the screen can comprise a material that isimpervious to fluids. In one alternative, the material can be providedalong edges or sides of the screen. In one alternative, the screen cancomprise a closure element for securing samples for storage ortransport. In one alternative, the closure element can comprise azipper, a zip-lock, an adhesive seal, a draw-string, a clip, or anelastic or conformable wire. In one alternative, the screen can comprisea transparent region that is compatible with imaging modalities fortissue analysis. In one alternative, the screen can be removable fromthe container along the edges or sides to permit visualization throughthe transparent region. In one alternative, the screen can comprise anarea for displaying information about the patient. In one alternative,the area can be configured to receive thereon a preprinted labelcontaining the information about the patient. In one alternative, thearea can be configured to permit a user to write thereon. In onealternative, the area can comprise a plurality of sub-areas fordisplaying preprinted information or clinician notes. In onealternative, the screen can be configured to fold with collapse of thecontainer. In one alternative, the folding of the screen can beconfigured to permit airflow to a drain/suction port. In onealternative, the screen can be configured to fold in an interleavedmanner. In one alternative, the screen can comprise a hole that is sizedor shaped to permit capture of clots, or intact tissue.

In some embodiments, the drape can comprise one or more labels. In onealternative, the one or more labels can comprise instructions for usingthe drape, and information on one or more of the following: location ofone or more access port holes, location of one or more perforations,location of one or more attachment points, areas at which sections ofthe drape can be detached, placement of the drape onto the patient,location of the drape relative to an operating table, attachment of thedrape to the operating table, location of the drape relative to one ormore support structures proximal to the operating table, or attachmentof the drape to the one or more support structures.

In some embodiments, the drape can comprise excess material in at leastthe first portion or the second portion to permit a non-sterile hand ofthe user from a non-sterile working space outside of the drape to accessand manipulate the transrectal device or a surgical arm withoutcontaminating a sterile field underneath the drape.

In some embodiments, a method of using the surgical drape can beprovided that can comprise providing a first portion comprising thecanopy portion, covering at least partially a surgical arm coupled tothe transrectal device and the proximal portion of the transrectaldevice such that the canopy portion is capable of moving with theproximal portion of the transrectal device when the transrectal deviceis supported by the surgical arm, and coupling the second portion to thefirst portion such that the second portion covers at least the portionof the torso of the patient.

In some embodiments, a surgical drape for covering a patient and antransrectal device during surgical treatment of the patient is providedwith a first portion that permits visual viewing of the transrectaldevice during the surgical treatment of the patient, and a secondportion coupled to the first portion, said second portion being sizedand shaped to cover at least a portion of a torso of the patient,wherein the second portion comprises a perforation extending along amidline of the second portion to assist in removal of the surgical drapefrom the patient. In one alternative, the first portion can comprise acanopy portion, wherein the canopy portion is sized and shaped to atleast partially cover a surgical arm coupled to the transrectal deviceand a proximal portion of the transrectal device, and the canopy portionis configured to move with the proximal portion of the transrectaldevice when the transrectal device is supported by the surgical arm. Inone alternative, the first portion of the drape can comprise an openingsized to receive a surgical probe to be inserted into a urethra of thepatient, and wherein the opening is located adjacent to the canopyportion. In one alternative, the first portion permits viewing of thetransrectal device through the first portion and maintains sterility ofthe surgical probe when the surgical probe is inserted into the urethraof the patient. In one alternative, the perforation of the secondportion extends to the opening. In one alternative, the canopy portioncan comprise a three-dimensional space sized and shaped to cover aproximal portion of the transrectal device such that the transrectaldevice is permitted to move in a non-restrictive manner within thethree-dimensional space. In one alternative, the canopy portion cancomprise a volume that is greater than a volume occupied by the proximalportion of the transrectal device. In one alternative, the volume of thecanopy portion can be at least two times greater than the volumeoccupied by the proximal portion of the transrectal device. In onealternative, the canopy portion can comprise a thin flexible materialhaving a thickness ranging from about 0.25 mm to about 3 mm. In onealternative, the canopy portion can be configured to collapse to lessthan its full volume in a free-standing configuration. In onealternative, the canopy portion can be configured to collapse to lessthan its full volume when the canopy portion can be covering theproximal portion of the transrectal device. In one alternative, thethree-dimensional space can define a volume within a range from about750 cm³ to about 70,000 cm³. In one alternative, the three-dimensionalspace can comprise a substantially rectangular shape. In onealternative, the three-dimensional space can be sized and shaped tocover proximal portions of a plurality of transrectal devices ofdifferent sizes and shapes. In one alternative, the canopy portion canbe configured to wrap around at least the surgical arm coupled to thetransrectal device or the proximal portion of the transrectal devicesuch that the canopy portion collectively moves with the surgical armand the proximal portion of the transrectal device. In one alternative,the first portion and the second portion can be detachably coupled toeach other. In one alternative, the first portion and the second portioncan be formed together as one piece. In one alternative, the firstportion and the second portion can be stitched together as one piece. Inone alternative, the first portion can be coupled to a cut-out formed inthe second portion. In one alternative, a container having an openingand configured to receive and store waste generated during the surgicaltreatment can be provided. In one alternative, the container cancomprise an attachment configured to releasably attach the container toan upper part of the second portion to support the container holding thewaste. In one alternative, the attachment can comprise tethers coupledto the upper part of the second portion from two sides of the opening ofthe container. In one alternative, the container can comprise aconnector at the bottom of the container configured to connect to asuction system. In one alternative, the container can comprise a screenattached to a lower inner side of the container, wherein the waste ispassed through the screen, and wherein the screen is configured tocollect the tissue. In one alternative, the container portion cancomprise a third sheet of material that is separable from a second sheetof material forming the canopy portion. In one alternative, the secondsheet of material can be impervious to liquids. In one alternative, thecontainer and the canopy portion can be formed from a same sheet ofmaterial. In one alternative, the second portion can comprise a firstsheet of material that is impervious to liquids.

In some embodiments, an apparatus that comprises a surgical drape and atransrectal device.

In some embodiments, a method of using the surgical drape can beprovided that comprises providing the first portion to permit visualviewing of the transrectal device during the surgical treatment of thepatient, coupling the second portion to the first portion such that thesecond portion covers at least a portion of a torso of the patient, andusing the perforation extending along the midline of the second portionto assist in removal of the surgical drape from the patient during orafter the surgical treatment.

In some embodiments, a surgical drape for covering a patient and antransrectal device during surgical treatment of the patient is provided.The drape can comprise a first portion that permits visual viewing ofthe transrectal device inserted into the patient, and a containerportion coupled to the first portion to receive and store wastegenerated during the surgical treatment, wherein the container portioncomprises an attachment to releasably attach the container to an upperpart of the surgical drape to support the container holding the waste.In one alternative, the attachment can comprise tethers coupled to theupper part of a second portion of the surgical drape from two sides ofan opening of the container. In one alternative, wherein the tethers canbe coupled to an operation table, a bed rail, a surgical arm, or to aphysician. In one alternative, the attachment can comprise a U-ringdevice configured to be attached to one side of an operation table. Inone alternative, the second portion can comprise a second sheet ofmaterial that is opaque. In one alternative, the second portion cancomprise a second sheet of material that is translucent. In onealternative, the second portion can be sized and shaped to cover atleast a portion of a torso of the patient. In one alternative, thetethers can comprise adhesive tabs and straps such that the straps arewrapped around a torso or legs of the patient and secured by theadhesive tabs. In one alternative, the tethers can be wrapped over anexterior surface of the second portion that covers the torso or legs ofthe patient. In one alternative, the container can comprise a drainagehole for draining the waste. In one alternative, the container cancomprise a connector at the bottom of the container configured toconnect to a suction system. In one alternative, the connector cancomprise an exit port with a sealing flange. In one alternative, thecontainer can comprise a screen attached to a lower inner side of thecontainer, wherein the waste is passed through the screen and whereinthe screen is configured to collect the tissue. In one alternative, thecontainer can comprise a third sheet of material that is separable froma first sheet of material forming the first portion. In one alternative,the third sheet of material can be impervious to liquids. In onealternative, the third sheet of material can comprise a translucentmaterial. In one alternative, the first sheet of material can beimpervious to liquids. In one alternative, the container can bedetachably coupled to the first portion. In one alternative, thecontainer can be below a canopy portion of the first portion. In onealternative, the first portion can comprise a translucent material,wherein the container and the first portion are formed from the samesheet of material.

In some embodiments, a method of using the surgical drape is providedthat can comprise providing the first portion to permit visual viewingof the transrectal device during the surgical treatment of the patient,attaching a container portion of the surgical drape to an upper part ofthe surgical drape to support the container holding the waste, andreceiving and storing the waste by the container portion.

In some embodiments, a method or surgical drape can be provided that cancomprise a second portion of the surgical drape configured to cover oneor more of a foot or a leg of the patient.

In some embodiments, a second portion of the drape comprises aperforation extending along, or at any angle or offset to, a midline ofthe second portion to assist in removal of the surgical drape from thepatient.

In some embodiments, the surgical drape is configured to cover one ormore of the feet or legs of the patient.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The patent or application file contains at least one drawing executed incolor. Copies of this patent or patent application publication withcolor drawing(s) will be provided by the Office upon request and paymentof the necessary fee.

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIGS. 1A and 1B show a perspective view of a patient and a surgicalsystem partially covered by a sterile drape in accordance with someembodiments of the invention;

FIG. 2 shows a first portion of a surgical drape, in accordance withsome embodiments;

FIG. 3A provides a planar view of the drape on the top side away fromthe patient; FIG. 3B provides a perspective view of the drape; and FIG.3C shows straps or tethers wrapped around the legs of the patient overthe drape, in accordance with some embodiments;

FIGS. 4A to 4C schematically illustrate a method of using the drape, inaccordance with some embodiments;

FIG. 5 illustrates a surgical drape comprising one or more framestructures in accordance with some embodiments;

FIG. 6 illustrates material of a surgical drape hanging loosely, orwrapped around the torso or underside of the legs of a patient orstirrups, in accordance with some embodiments;

FIG. 7 illustrates a surgical drape comprising a viewing window andmounted to a support structure having a graphical display, in accordancewith some embodiments;

FIG. 8 illustrates a container having a substantially rectangular funnelshape in accordance with some embodiments;

FIG. 9A illustrates a container with vertical stiffening pleats formaintaining a structural form of the container, in accordance with someembodiments;

FIG. 9B illustrates a container with horizontal cylindrical stiffeningpleats to create hoop strength for maintaining a structural form of thecontainer, in accordance with some embodiments;

FIGS. 10A to 10D illustrates the use of a container as a packagingenclosure for storing a surgical drape, in accordance with someembodiments;

FIG. 11 illustrates a container coupled to and carried by a user inaccordance with some embodiments;

FIG. 12 illustrates a container comprising one or more compliantstiffening elements for maintaining a structural form of the container,in accordance with some embodiments;

FIG. 13 illustrates a container comprising an integral perforated tubingmatrix for maintaining fluid flow and air displacement, in accordancewith some embodiments;

FIG. 14 illustrates a container comprising tube-like areas formed fromrolled up drape material, that may be connected to a drain/suction portfor maintaining fluid flow and air displacement, in accordance with someembodiments;

FIG. 15 illustrates a container comprising a flap to prevent splash ontoa user, in accordance with some embodiments;

FIG. 16 illustrates a container comprising one or more ports foraccepting fluids from an irrigation or aspiration pump, or from a drainline above or below a screen, in accordance with some embodiments;

FIG. 17 illustrates a container comprising extruded portions that definean inner sterile surface and an external non-sterile surface, inaccordance with some embodiments;

FIG. 18 illustrates a container comprising a detachable screen inaccordance with some embodiments;

FIG. 19 illustrates a screen that can be configured to fold withcollapse of the container in accordance with some embodiments;

FIG. 20 illustrates a canopy portion designed such that fluid isconducted to flow downwards toward the container when the canopy portionis in an inverted configuration, in accordance with some embodiments;

FIG. 21 shows a surgical drape comprising labels, in accordance withsome embodiments;

FIG. 22A shows thermoforming with a mold and sheet material, inaccordance with some embodiments;

FIG. 22B shows a surgical drape thermoformed over a mold, in accordancewith some embodiments;

FIG. 23A shows a user manipulating a transrectal device through a canopyportion of a surgical drape and a corresponding first position of aproximal portion of the transrectal device, in accordance with someembodiments;

FIG. 23B shows the user manipulating the proximal portion of thetransrectal device of FIG. 23A and a corresponding second position ofthe proximal portion of the transrectal device, in accordance with someembodiments;

FIG. 23C shows return of a portion of the canopy portion toward thefirst position of FIG. 23A, in accordance with some embodiments;

FIG. 24A shows a full volume of a canopy portion in an extendedconfiguration;

FIG. 24B shows a decreased volume of the canopy portion of FIG. 24A in apartially collapsed configuration, in accordance with some embodiments;

FIG. 25A shows a surgical drape coupled to an actuation element in acompact configuration in a side profile view, in accordance with someembodiments;

FIG. 25B shows the surgical drape of FIG. 25A in an extended profileconfiguration in a side profile view, in accordance with someembodiments;

FIG. 25C shows the surgical drape of FIG. 25A in the compact profileconfiguration in a top profile view, in accordance with someembodiments;

FIG. 26 shows an opening sized to receive a surgical urological probeand perforations extending in a first direction corresponding toinferior and superior directions of a patent and perforations extendingin second direction transverse to the first direction to allow thesurgical drape to be removed around a base of a tensioning devicecoupled to a patient with a catheter extending along the urethra of thepatient, in accordance with some embodiments;

FIG. 27 shows a container portion of a surgical drape with a porousstructure upstream of a suction port, in accordance with someembodiments;

FIG. 28 shows a container with a viewing window, in which the containeris sized to receive a porous structure with solid material from thepatient supported thereon, in accordance with some embodiments; and

FIG. 29 shows an image of surgical drape used to conduct experimentaltesting, in accordance with some embodiments.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying figures, which form a part hereof. In the figures, similarsymbols typically identify similar components, unless context dictatesotherwise. The illustrative embodiments described in the detaileddescription, figures, and claims are not meant to be limiting. Otherembodiments may be utilized, and other changes may be made, withoutdeparting from the scope of the subject matter presented herein. It willbe readily understood that the aspects of the present disclosure, asgenerally described herein, and illustrated in the figures, can bearranged, substituted, combined, separated, and designed in a widevariety of different configurations, all of which are explicitlycontemplated herein.

The methods and apparatus of the present disclosure are well suited forcombination with many types of surgical instruments and robotic surgerydevices, for example as described in PCT Application No.PCT/US2013/028441, filed on Feb. 28, 2013, entitled “AUTOMATEDIMAGE-GUIDED TISSUE RESECTION AND TREATMENT”, the entire disclosure ofwhich are incorporated herein by reference, and suitable for combinationin accordance with embodiments disclosed herein.

As used herein, the terms proximal and distal in the context of theapparatus refer to proximal and distal as referenced from the apparatusoutside the patient, such that proximal may refer to components outsidethe patient or nearer the operator and distal may refer to componentsinside the patient or further from the operator.

As used herein, the terms proximal and distal in the context ofanatomical locations are with respect to the operator of the apparatus,such that proximal may refer to anatomical locations nearer the operatorand distal may refer to anatomical locations further from the operator.

As used herein, the terms distal and proximal refer to locationsreferenced from the apparatus and can be opposite of anatomicalreferences. For example, a distal location of a probe may correspond toa proximal location of an elongate member of the patient, such as apenis of the patient, and a proximal location of the probe maycorrespond to a distal location of the elongate member of the patient.

Although specific reference is made to treatment of the prostate, themethods and systems disclosed herein can be used with many tissues. Forexample, the embodiments disclosed herein may be used in any urological,gynecological or proctological procedures. Embodiments as disclosedherein may be used in any surgical procedures to treat any tissue cavitycomprising a proximal opening and a distal opening, the proximal anddistal openings allowing the tissue volume to fluidly communicate withother organs or parts of the body adjacent the tissue volume. Forexample, although specific reference is made to the advancement of ahemostasis device through the urethra into the prostate, and through thebladder neck into the bladder, the hemostasis device as described hereinmay be advanced through any proximal opening of a tissue cavity into thecavity, and through any distal opening of the tissue cavity into anotherorgan or body part adjacent the tissue volume.

The surgical systems that are protected by the drape may relate to theadministration of a hemostatic material or sealant to fill in whole, orin part, any bleeding closed tissue volume. Such tissue volumes maycomprise tissue spaces or voids occurring naturally, for example ananeurysm, fissure, or postpartum hemorrhage of the uterus. Such tissuevolumes may for example be formed as a result of tissue removal ofunnecessary or undesirable growths, fluids, cells, or tissues. Thesurgical systems as utilized in the surgical procedures are well-suitedfor treating closed tissue volumes remaining after tumor resection,endometrial ablation, polyp removal, cyst removal, and the like.

The surgical systems involved in the surgical procedures may bewell-suited for treating many types of closed tissue volumes such aswithin rectum, prostate, uterus, cervix, liver, kidney, bowel, pancreas,muscle, and the like.

The surgical system or at least part of the surgical system can besterilized by normal methods that are compatible with the device, suchas steam, heat and pressure, chemicals and the like.

FIGS. 1A and 1B show a perspective view of a patient 20 and a surgicalsystem 10 partially covered by a sterile drape 100 in accordance withsome embodiments. The surgical drape 100 may be substantially flexibleand may be impervious to liquids, such as bodily fluids. The surgicaldrape 100 may comprise a first portion 110 coupled to a second portion130. The second portion may comprise a non-transparent or opaque portionand the first portion may comprise an optically transmissive material,such as one or more of a visually translucent material, a visuallytranslucent material, or semi-transparent material, whereby at least aportion of light is permitted to pass through the material to allow atleast partial visualization through the material. For example, atransparent material or a translucent material may allow most of thelight in the visible spectrum to pass through and allow at least partialvisualization through the material. A semi-transparent material orsemi-translucent material may allow only a portion of the visible lightor certain wavelengths of light to pass through, thereby resulting invisibility being reduced to some extent. The first portion 110 may be atleast partially transparent to the visible light spectrum, such that auser can see through the portion to view an underlying object.

As shown in FIGS. 1A and 1B, the surgical drape 100 may be sized andshaped to cover at least a portion of a surgical system 10. The surgicalsystem 10 may comprise an imaging probe 12 for imaging tissue in apatient's body. The imaging probe 12 may comprise, for example anultrasonography probe. The imaging probe may comprise a transrectalultrasound (TRUS) or other imaging modalities for providing real timeimage guidance to a physician during a surgical procedure. The imagingprobe 12 may be coupled to an articulating or mechanical arm 14configured to support and/or actuate the imaging probe. For example, theimaging probe may be operably coupled to a distal portion of themechanical arm, and a proximal portion may be coupled to an operationtable or stand. The mechanical arm may be configured to provide one ormore degrees of freedom of motion to the imaging probe. For example, themechanical arm can be used to move the imaging probe along alongitudinal axis towards a target tissue of the patient.

The surgical drape 100 may comprise a first portion 110 comprising acanopy portion 111. Part or all of the first portion 110 may comprise avisually transparent or translucent material. In some cases, part of thefirst portion 110 may be visually transparent or translucent, whileanother part of the first portion may be opaque. The canopy portion 111may preferably comprise a visually transparent or translucent material.The canopy portion 111 can be provided or disposed anywhere on the firstportion 110, for example at the center, edge, corner, top, bottom,and/or side of the first portion. The canopy portion 111 can beintegrally formed with the first portion 110 or as part of the firstportion. Alternatively, the canopy portion 111 may be provided as aseparate piece from the first portion 110 such that the canopy portioncan be fixedly or detachably coupled to the first portion. In somecases, the first portion 110 may comprise a cut-out or openingconfigured to couple to the canopy portion 111. For example, the cut-outor opening of the first portion may be sized and shaped to match thecanopy portion 111, as described elsewhere herein.

The canopy portion 111 may be sized and shaped to substantially cover aproximal end of the imaging probe 10. In some embodiments, the canopyportion 111 may comprise a three-dimensional configuration that providesa working space for the imaging probe 12 to move in an un-restrictedmanner therein, for example with less physical impedance orinterference. The imaging probe can be an ultrasonography probe having aproximal portion 12-1 that is supported by the articulating ormechanical arm 14. The first portion 110 or the canopy portion 111 maybe configured to at least partially cover the mechanical arm coupled tothe ultrasonography probe and/or the proximal portion of theultrasonography probe. The surgical drape 100 may also comprise a secondportion 130 coupled to the first portion 110. The first portion 110 andthe second portion 130 may be fixedly or detachably coupled to eachother. The second portion 130 may be sized and shaped to cover at leasta portion of a torso 22 of the patient. As previously described, thesecond portion 130 may be a non-transparent or opaque portion, althoughthe invention is not limited thereto. In some cases, one or more partsof the second portion 130 can be visually transparent or translucent.

The surgical drape may cover at least a portion of an articulating ormechanical arm 14 of the imaging probe. In some cases, the entireimaging probe including the articulating arm and a base from which thearm extends may be covered by the surgical drape. In some situations,the entire imaging probe may be covered by the drape to create a sterilebarrier to physically separate the imaging probe from the operation areaof the patient.

As mentioned previously, the surgical drape may be compatible withsurgical systems utilized in male urology surgical procedures orprostate surgery. In some embodiments, the surgical system may comprisea treatment probe 16 (e.g. shown in FIG. 1B) and an imaging probe. Thepatient may be placed on a patient support (e.g., examination table oroperation table), such that the treatment probe and the imaging probe(e.g. ultrasound probe) can be inserted into the patient. The patientcan be placed in one or more of many positions such as prone, supine,upright, or inclined, for example. In some embodiments, the patient maybe placed in a lithotomy position, and stirrups may be used, forexample. The treatment probe and the imaging probe can be inserted intothe patient in one or more of many ways. In some embodiments, theimaging probe may be inserted into the rectum of the patient and thetreatment probe may be inserted into the urethra of the patient, and thedrape disclosed herein may provide a transparent sterile barrier betweenthe urethra and rectum. In some situations, the imaging probe is notsterilized, and a sterile barrier may be provided to physically separatethe imaging probe from the operation area of the patient.

In some cases, insertion of the treatment probe (e.g., sealant deliverydevice, tissue resection device) and/or delivery of sealant to a cavityor the tissue may be guided by the imaging probe. The imaging probe maybe an ultrasonography probe. The imaging probe can comprise atransrectal ultrasound (TRUS) or other imaging modalities for providingvisual guidance. TRUS may be used to guide actuation of the catheterduring sealant delivery, for example by retracting or advancing thecatheter within the cavity by mechanical or manual means.

In some embodiments, the treatment probe may comprise a handpiece. Insome cases, the treatment probe may be configured to image the targettissue. The treatment probe may comprise an elongate structure having aworking channel sized and shaped to receive an endoscope and a carrierof a carrier tube. The carrier may be configured to direct and scan alight beam on the treatment area to determine a profile of the tissueremoved. The carrier may also be configured to release a fluid streamcomprising a waveguide and scan the light pattern of the fluid streamcomprising the waveguide. The treatment probe may be a urethral probefor tissue resection volumetric tissue removal. For example, thetreatment probe may direct a fluid stream radially outwardly forcontrolled resection of tissue such as the prostate and luminal tissues.Optionally, the fluid stream may be used to deliver light, electrical,heat or other energy sources to aid in resection and/or to cauterize thetreated tissue. Alternatively, the treatment probe can be any tools orrobotic devices that can perform or assist in the urologic surgery withor without manual operations.

The imaging probe may comprise or be supported by an articulating arm ormechanical arm 14 extending from the base. The mechanical arm may beconnected to a proximal end 12-1 of the elongate imaging probe 10. Insome embodiments, the articulating arm or mechanical arm may comprise anactuator 117 to manipulate the imaging probe under user control. In somecases, the entire or at least a portion of the base or the articulatingarm may be covered by the drape, and the proximal end of the imagingprobe may be entirely covered by the canopy portion of the drape. Forinstance, as shown in FIGS. 1A and 1B, the proximal end of the TRUSprobe may be covered by the canopy portion of the first portion of thesurgical drape, and the articulating arm may be covered by a non-canopyportion of the first portion.

The imaging probe, for example a distal portion 12-2 of the imagingprobe 10, can be inserted into the patient in one or more of many ways.The imaging probe can comprise an ultrasonography probe. A proximalportion of the ultrasonography probe may be mounted on the articulatingor mechanical arm 14 and a distal portion 12-2 of the ultrasonographyprobe may be inserted into the patient. During insertion, thearticulating arm 14 may have a substantially unlocked configuration suchthat the imaging probe can be desirably rotated and translated in orderto insert a distal portion 12-2 of the probe into the patient. When theimaging probe has been inserted to a desired location within thepatient, the articulating or mechanical arm 14 can be locked. In somecases, the imaging probe and the treatment probe may be inserted intothe patient sequentially or concurrently. In a locked configuration ofthe imaging probe, the imaging probe and/or the treatment probe can beoriented in relation to each other in one or more of many ways, such asparallel, skew, horizontal, oblique, or non-parallel, for example. Itcan be helpful to determine the orientation of the probes with sensorssuch as angle sensors, in order to map the image date of the imagingprobe to coordinate references of the treatment probe. Having the tissueimage data mapped to treatment probe coordinate reference space canallow accurate targeting and treatment of tissue identified fortreatment by an operator such as the physician. Accordingly, it is idealfor the imaging probe to be capable of moving with unimpeded and fewrestrictions while being covered by the surgical drape.

In some embodiments, the treatment probe 16 may be coupled to theimaging probe, in order to align treatment with the treatment probebased on images from imaging probe. The coupling can be achieved using abase that is common to the treatment probe and the imaging probe. Theimaging probe can be coupled to the base with the articulating ormechanical arm 14, which can be used to adjust the alignment of theimaging probe when the treatment probe is locked in position. Thearticulating or mechanical arm 14 may comprise a lockable and movableprobe under control of an imaging system or of the console and of a userinterface, for example. The articulating or mechanical arm 14 may bemicro-actuable so that the proximal end 12-1 of the imaging probe 12 canbe adjusted with small movements, for example a millimeter or so inrelation to the treatment probe.

The movement of the imaging probe 12 or the proximal end 12-1 of theimaging probe may range from millimeters to centimeters. For instance,the proximal end of the imaging probe may move within a space having adimension (e.g., length, width, height, diameter, diagonal) of at least10 cm, 20 cm, 30 cm, 40 cm, 50 cm, 60 cm, 70 cm, or 80 cm. The proximalend of the imaging probe may be configured to move freely with respectto up to six degrees of freedom (e.g., three degrees of freedom intranslation and three degrees of freedom in rotation).

As shown in FIGS. 1A and 1B, the canopy portion 111 provides a workingspace or volume 114 for the imaging probe 12 to move therein withreduced restrictions. The working space 114 is helpful to reducephysical interference between the imaging probe and the drape when theimaging probe moves. In some cases, the canopy portion may be configuredto move with the proximal end of the imaging probe 12 as a whole whilethe remaining portion of the drape is still supported in place.Additional details regarding the canopy portion are described laterherein.

The surgical drape 100 may comprise an aperture or fenestration 118allowing access to the urethra by the treatment device or probe. Thefenestration 118 may allow access to the organ that is isolated from theremainder of the patient's body covered by the drape. Alternatively, thefenestration 118 may allow access of a surgical instrument through thedrape. The aperture or fenestration may be a through hole formed in thesecond portion 130 of the surgical drape or the first portion 110 of thesurgical drape. The aperture or fenestration, in some embodiments, maybe located adjacent to the canopy portion 111.

The surgical drape may be removable from the patient or the surgicalsystem. Removal of the drape can be achieved by a perforation 132 whichmay extend along or be at any angle to a midline of the drape to thefenestration. This is helpful to provide an easy removal of the drapeafter the urology procedure with instruments like catheters still inplace. In some embodiments, the perforation 132 need not extend alongthe midline of the drape, and may be offset from the midline of thedrape by a distance, for example around 5 cm, 10 cm, 20 cm, 30 cm, 40cm, or 50 cm. In some cases, perforation may include various othermechanisms such as zipper, buttons, sliders, ripcords and the like.

The surgical drape may further comprise a container portion 140 forreceiving waste generated during the surgical procedure. For example, inthe male urology procedure, it is common that sizable amounts of liquidsmay be released from the urethra or other instruments. The containerportion 140 can be a collection repository for body and irrigationfluids flowing from the patient during examination and surgery. In someembodiments, the container portion 140 may comprise a hole 142 allowingbodily fluids exiting therefrom. The container portion 140 may include adrainage area and/or funnel, which can direct body and irrigation fluidsto another container situated below the container portion. Moreover, thecontainer portion 140 may provide effective fluid management and may becompatible with a suction irrigation system. In some cases, thecontainer may comprise an opening and configured to receive and storewaste including bodily fluids, surgical-related fluids, tissue or debrisgenerated during the surgical treatment.

The surgical drape may comprise attachment 150 to assist in locating andsupporting the container portion 140 in position, particularly when thecontainer is holding fluids contributing additional weight to thecontainer. The attachment may be a component of the surgical drape orthe container portion. The attachment may be a standalone elementreleasably attached to the surgical drape or the container portion. Theattachment is useful for supporting the container portion when thecontainer is holding fluids. For instance, in the event of a malfunctionin the suction irrigation system, a sizable amount of fluids may bedisposed into the container, and the drape may sag downwards due to theweight of the liquids in the container. The attachment 150 may comprisetethers or straps to support the container and prevent the drape fromsagging. The tethers or straps can be attached from an opening side ofthe container portion to the legs 24 of the patient or the operationtable. For example, the straps or tethers may be wrapped around the legs24 of the patient over the drape or may be affixed to the operationtable. The tethers can be coupled to a bed rail, a surgical arm, or to aphysician. In some cases, the straps or tethers may be attached to agarment/gown of the physician, or attached to a halter that thephysician wears around his or her neck. In some cases, the attachmentmay comprise a U-ring device configured to be attached to one side of anoperation table, or an end of an operating table. Accordingly, theattachment 150 can allow the weight of the container portion to bepartially supported by the legs of the patient or the operation table.The legs of the patient may be covered by the second portion 130 or thefirst portion 110 of the drape. The legs of the patient may or may notbe visible by a physician through the drape.

FIG. 2 shows a first portion 110 of a surgical drape, in accordance withsome embodiments. The first portion 110 may comprise a single sheet ofmaterial or multiple sheets of material, such as extruded or coextrudedmaterial. In some embodiments, the first portion may comprise multiplesheets of a same material that are stacked together. In otherembodiments, the first portion may comprise multiple sheets of differentmaterials that are stacked or sandwiched together. The first portion 110may comprise a visually transparent or semi-transparent portion. Thefirst portion may comprise, for example, clear plastics, or a latex thinfilm. The first portion may or may not have color. The first portion maybe clear without color. Alternatively, the first portion may have colorsuch as blue, green, yellow, red, or any other colors. The first portionmay comprise a uniform color or a mixture of various different colors.The sheet(s) of material used for the first portion may be constructedfrom readily available plastic films used in the medical field, forexample, vinyl (such as polyvinyl chloride), polyethylene,polypropylene, polycarbonate, polyester, silicon elastomer, acetate andso forth.

The sheet of material used for the first portion 110 may be atransparent or translucent material that permits a user to see-throughthe portion during insertion or operation of an imaging probe. The sheetof material may be translucent whereby at least a portion of light ispermitted to pass through the material. The sheet of material may be atleast partially transparent to the visible light spectrum, such that auser can see through the portion to view an underlying object. The sheetof material may allow visual viewing of a non-sterile instrumentinserted into the patient such as an imaging probe.

The sheet of material used for the first portion 110 may be imperviousto liquids. For example, the material may be a hydrophobic material toprevent moisture absorption by the drape. The sheet of material used forthe first portion may possess a desirable stiffness or flexibility suchthat an operator is able to move an articulating arm coupled to theimaging probe without tearing the first portion. The sheet of materialused for the first portion may be configured having a predeterminedbending stiffness, or a range of bending stiffness values. In anotherexample, the sheet of material may have tensile modulus in a range of0.1 GPa to 5 GPa, where GPa refers to the tensile modulus in gigapascalas will be understood by one of ordinary skill in the art. A materialmay be harder grade when the tensile modulus is greater. A material maybe flexible or soft when the tensile modulus is small.

In selecting a sheet material for use in the first portion, factors suchas softness of the sheet, breathability, adaptability of the sheet tothe body contour of a patient, patient comfort, or canopy portionstiffness properties can be evaluated in conjunction with the thicknessof the sheet. For instance, a sheet made of a soft material may beprovided having a greater thickness than a sheet made of a harder gradematerial, in order to provide similar stiffening effects. The type ofmaterial and its thickness may be selected such that the canopy portionof the first portion may be configured to collapse to less than its fullvolume when the canopy portion is covering the proximal portion of theimaging probe, e.g. ultrasonography probe. Additionally, the type ofmaterial and its thickness may be selected such that an operator is ableto manipulate an articulating arm through the surgical drape withouttearing any portion of the drape. In some embodiments, the canopyportion or the first portion of the drape may comprise a thin flexiblematerial having a thickness raging from about 0.05 mm to about 3 mm, forexample from about 0.25 mm to about 3 mm. Alternatively, the thicknessof the first portion or the canopy portion can be less than 0.25 mm orgreater than 3 mm. For example, the thickness of the first portioncomprising the canopy portion may comprise a thin flexible materialhaving a thickness within a range from about 0.05 mm to about 3 mm.

The first portion may comprise a canopy portion 111. The canopy portion111 may comprise a shape and dimension to cover at least a proximal endof an imaging probe as described elsewhere herein. The canopy portion111 may comprise a three-dimensional space 114 sized and shaped to coverthe proximal portion of the imaging probe such that the imaging probe ispermitted to move in a non-restrictive manner within thethree-dimensional space. The space 114 provided by the canopy portionmay be sufficient to accommodate movement of the imaging probe, withoutthe canopy portion or other portions of the drape interfering with themovement of the imaging probe. The space 114 provided by the canopyportion may be greater than a working space required by the imagingprobe. The canopy portion can be adapted for imaging probes of differentsizes and dimensions. For example, the space provided by the canopyportion may be greater than the size or dimension of the imaging probeby at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 200%, ormore. The space provided by the canopy portion may be defined by avolume, for example, 30-50 cm by 10-30 cm by 10-30 cm. Thethree-dimensional space may comprise a volume ranging from about 750 cm³to about 70,000 cm³. In some cases, the volume of the three-dimensionalspace may be less than 750 cm³ or greater than 70,000 cm³.Alternatively, the space provided by the canopy portion may be definedby volumes at least or greater than 40 cm×45 cm×25 cm, 45 cm×45 cm×30cm, or 50 cm×50 cm×30 cm. The canopy portion may comprise a space havinga volume that is greater than a volume occupied by the proximal portionof the ultrasonography probe. For example, the volume of the spaceprovided by the canopy portion may be at least two times greater thanthe volume occupied by the proximal portion of the ultrasonographyprobe. The canopy portion may comprise any type of material, shapeand/or dimensions that allows the canopy portion to collapse to lessthan its full volume in a free-standing configuration, such that thecanopy portion can be wrapped around the proximal portion of theultrasonography probe or cover the proximal portion of theultrasonography probe. The canopy portion is described to be in afree-standing configuration when the canopy portion is not covering anyunderlying object, and is allowed to collapse to a substantiallyflattened shape under its own weight. It is noted that the volume of thethree-dimensional space of the canopy portion may be substantiallyreduced when the canopy portion is in a free-standing configuration (ascompared to when the canopy portion is covering the imaging probe orproximal portion thereof). In some cases, the volume of thethree-dimensional space of the canopy portion may be reduced by 50%,60%, 70%, 80%, 90%, or more than 90% when the canopy portion is in thefree-standing configuration.

The canopy portion 111 may comprise any three-dimensional shape such ascube, orb, cylinder, cone, semi-sphere, cuboid, triangular prism,hexagonal prism, pyramid, self-supporting geodesic dome, and variousother forms. In some cases, the canopy portion may comprise a cuboidshape or rectangular shape. The three-dimensional shape of the canopyportion may comprise any number of facets or edges where the adjoiningfacets meet. For example, the three-dimensional shape may include one,two, three, four, five, six, seven, eight, nine, ten or more facets. Thethree-dimensional shape of the canopy portion can be formed using anymanufacturing or fabrication methods known to those skilled in the art.For instance, the canopy portion can be formed by a thermoformingprocess to mold a sheet of plastic material into a desiredthree-dimensional geometry or by joining a plurality of pieces ofmaterial together such as using heat sealing.

In some cases, the first portion 110 may comprise a base portion 116connected to the canopy portion. The base portion 116 may be an outersection of the first portion. The base portion may be a substantiallyflat portion of the first portion and may be configured to wrap aroundat least the mechanical arm coupled to the ultrasonography probe or theproximal portion of the ultrasonography probe, such that the canopyportion collectively moves with the mechanical arm and the proximalportion of the ultrasonography probe. The canopy portion 111 maycomprise a separate sheet of material that is attachable to the baseportion 116. The first portion may comprise a first sheet of material,and the canopy portion 111 may comprise a second sheet of material thatmay or may not be the same as the first sheet of material. The canopyportion 111 may be attached to the outer section of the first portion110 or the base portion 116. For example, the edges of the opening ofthe canopy portion may be sealed or sewn to the inner edges 124 of theouter section of the first portion or the base portion 116. The inneredges 124 may also be referred to as the inner cut-out of the outersection of the first portion. The inner cut-out of 124 may comprise ashape and dimension to match the opening of the canopy portion. Thecanopy portion can be coupled to the outer section of the base portionin a variety of ways. For example, the edges of the opening of thecanopy portion may comprise flanges to seal the canopy portion of theinner cut-out of the outer section of the base portion 116. The inneredges or the inter cut-out 124 of the outer section of the first portionor the base portion 116 may define a hole 122 therein. The canopyportion may be attached to the outer section of the first portion or thefirst portion 116 to cover the hole 122. Alternatively, the canopyportion may be integrally formed with the first portion. For example,the canopy portion may be formed from the same sheet of material as thefirst portion. The canopy portion may be visually transparent orsemi-transparent to allow viewing of the imaging probe and/or alignmentof the probe to the patient's body.

The first portion 110 may be coupled to the second portion 130 and acontainer portion 140 of the drape 100. FIG. 3A provides a top planarview of the drape 100 as seen from above the patient, and FIG. 3Bprovides a perspective view of the drape 100.

In some embodiments, the first portion 110 may comprise a fenestration118 sized and shaped to receive a treatment probe to be inserted into aurethra of the patient. Alternatively, the fenestration 118 can beformed in the second portion 130. In some cases, the fenestration 118may be formed in the first portion 110 above the canopy portion 111. Thefirst portion 110 may permit viewing of the ultrasonography probe andcan maintain sterility of the treatment probe when the treatment probeis inserted into the urethra of the patient. The fenestration 118 may beformed having any shapes such as circular, rectangular, square andvarious others. The fenestration 118 may have any dimension. Forinstance, the fenestration may have a diameter or length in a range ofabout 1 cm to 20 cm.

In some cases, the fenestration 118 may comprise reinforcement elements120 attached to the peripheral of the fenestration to providereinforcement to the fenestration upon insertion of an instrument ormale organ. The reinforcement elements 120 may comprise a diaphragmsurrounding the fenestration or partially surrounding the fenestration.The reinforcement elements can comprise a material which possesses thesame degree of flexibility and rigidity as, or may be softer or morerigid, than the material used for the fenestration/transparent portion.The reinforcement elements may comprise opaque, translucent ortransparent materials, and these reinforcement elements may providevisual contrast to enhance identification of the fenestration. Thereinforcement elements may comprise materials that are flexible orelastic, and that possesses sufficient rigidity to prevent an instrumentsuch as a treatment probe from penetrating or tearing the drape. In somecases, the reinforcement elements may comprise an elastic gather thatcinches around the organ for maintaining integrity of the sterile field.Alternatively, the reinforcement elements may comprise an adjustableclosure to cinch around the organ for maintaining integrity of thesterile field. Additionally or optionally, the reinforcement elementsmay comprise an adhesive material to gather drape and attach around theorgan for maintaining integrity of the sterile field.

The surgical drape may comprise a container portion 140 for managementof fluids generated during a surgical procedure. The container portion140 may comprise a sheet of material which is impervious to liquids. Thecontainer portion 140 may be removable or releasably attached to otherparts of the drape. For instance, the container portion may be a liquidpouch that can be attached to a lower portion of the drape under thecanopy portion. The liquid pouch may be attached to the drape via anysuitable means such as, for example, strips, ribbons, buttons,self-adhesive strips or tabs. Alternatively, the container portion 140may be integrally formed with the first portion. In some embodiments,the container portion 140 and the first portion of the drape may beformed from the same sheet of material. In some cases, the containerportion 140 may comprise joined edges 146 such that the sheet ofmaterial in a triangular shape may be folded and joined at the joinededges to form the pouch. Alternatively, the container portion 140 maynot be formed with the joined edges. As illustrated in FIG. 3A, thecontainer portion 140 may be positioned below the canopy portion 110 toreceive fluids flowing downwards.

The container portion 140 may comprise any shape that aids in collectingand/or directing fluids to flow towards the exit port. In someembodiments, the container portion may comprise a substantially conicalfunnel shape to allow fluids to drain to the exit port. In anotherexample, the container portion may comprise a substantially rectangularform having an angled or sloped bottom that allows fluids to drain tothe exit port.

The container portion 140 may include a drainage area and/or funnel fordirecting body and irrigation fluids to another container or suctionsystem (not shown). For example, the container portion may comprise ascreen 148 attached to a lower inner side of the container portionallowing bodily fluids passing through. The screen 148 may comprise meshwith pores to prevent clogging of the exit port 144. The pore size mayvary in a range, for example, from 1 mm to 20 mm. In some cases, thewaste is passed through the screen, and the screen is configured tocollect the tissues or debris generated during the surgical treatment.In some instances, the debris or tissues collected by the screen may beused for further diagnosis or analysis. In some instances, if thecontainer portion prolapses, the screen may bunch up to allow airflow tothe exit port. In some cases, the screen 148 may be detachable from thecontainer portion, and can be sealed and used as storage container forcontaining the collected samples. In some cases, the screen 148 may havesides made from material that is impervious to fluids to eliminate dripsduring storage or transport. In some cases, the screen may have aclosure (zipper, zip-lock, adhesive seal, draw-string, clip, elastic,conformable wire, etc.) for securing the collected samples for storageor transport. In some cases, the screen 148 may comprise a transparentportion compatible with imaging modalities for tissue analysis.

The container portion can provide effective management of fluids, andcan be compatible with a suction irrigation system. In some embodiments,a suction irrigation system may be provided, and the container portionmay comprise an exit port 144 at the bottom of the container configuredto connect to the suction irrigation system. For example, the containerportion may comprise an exit port with a sealing flange at the bottom ofthe container portion to be connected to a suction irrigation system(not shown).

The container portion 140 may comprise attachment 150 to support thecontainer when it holds fluids. The attachment 150 may be used to attachan opening of the container portion to an upper portion of thenon-transparent portion of the drape, in order to support thefluid-holding container. The attachment 150 may comprise straps ortethers that prevent the drape from sagging. For example, the straps ortethers may be used to attach an opening side of the container portionto the legs of the patient or to the operation table. For example, asillustrated in FIG. 3C, the straps or tethers 150 may be wrapped aroundthe legs 24 of the patient over the drape. The straps or tethers mayalso be affixed to the patient using adhesive tape provided at the endof the straps or tethers 150. Alternatively, the straps or tethers canbe attached to the operation table, structures mounted to the operationtable, or to the drape. The straps or tethers can be rolled up or foldedprior to use (as shown in FIG. 3A). For example, the straps or tethersmay be folded and secured by securing tapes 152 prior to use. The strapsor tethers 150 may have a length of at least 50 cm, 100 cm, 120 cm, 130cm, 140 cm, 150 cm, 160 cm, 170 cm, 180 cm, 200 cm, or 250 cm. Anynumber or type of attachments can be used for holding the containerportion in place. Although the illustrated invention shows two tethersattached to both sides of the opening of the container, any number oftethers (e.g. two or more) or any form of attachments (e.g., adhesives,anchoring mechanisms, Velcro, etc.) may be used to support the containerportion.

The surgical drape 100 may comprise a second portion 130 coupled to thefirst portion 110. The second portion may be a non-transparent or opaqueportion. The non-transparent portion may comprise a standard medicalnon-woven disposable material, and can be more opaque to provide privacyfor the patient. The non-transparent portion may comprise a materialthat is impervious to liquids. The non-transparent portion may be sizedand shaped to cover a torso 22 of the patient. The non-transparentportion may be sized and shaped to cover substantially the patient'sbody and at least part of the surgical system. For example, thenon-transparent portion may cover a portion of the imaging probe. Insome embodiments, the non-transparent portion may optionally and furthercomprise features such as slits 136 as shown in FIG. 3A to provideflexibility. The non-transparent portion can comprise any shape such asrectangular, triangular, square, or any other irregular shapes.

The first portion 110 and the second portion 130 may be detachablycoupled to each other. Alternatively, the first portion 110 and thesecond portion 130 may be formed together as one piece. The firstportion 110 and the second portion 130 may be stitched together as onepiece. In some embodiments, as illustrated in FIG. 3A, the first portionmay be coupled to a cut-out 134 of the second portion. The cut-out mayallow the surgical system or the imaging probe to be more easily viewedby an operator through the first portion.

The second portion 130 may be configured to cover or wrap aroundpatient's legs 24. The non-transparent portion may be wrapped aroundlegs of a patient as leggings such that a tether or strap for holdingthe container portion can be affixed to the legs by wrapping around themover the leggings (as shown in FIG. 3C). The second 130 may or may notextend all the way down to the floor.

The surgical drape 100 may comprise a separable line or perforation 132along a midline of the surgical drape, or at any angle to the midline ofthe surgical drape. The perforation 132 may extend from an edge of thenon-transparent portion to the fenestration. Alternatively, theperforation may not extend to the fenestration. The perforation mayassist in removal of the drape after a urology procedure wheninstruments such as catheters are still in place. The perforation mayalso allow easy separation of the adjoining surfaces of the surgicaldrape. In some embodiments, the perforation may comprise a segment 132-1located in the first portion 110 of the drape and a second segment 132-2located in the second portion 130 of the drape. In some embodiments, theperforation need not be positioned along the midline or central-line ofthe surgical drape. The perforation can be positioned anywhere on thedrape, in a configuration permitting the drape to be split from one sidethrough the fenestration without interference with instruments placedthrough the fenestration. In some cases, tapes 133 may be used tostrengthen the perforation region. The tapes 133 may serve to provide asealed barrier. The tape 133 may be applied to one side or both sides ofthe region where the perforation forms. The tapes 133 may be disposed ontop and/or below the perforation and the tape may be impervious tofluids. For example, the tape may comprise a first tape layer on top ofthe perforation and a second tape layer below the perforation such thatthe perforation is sandwiched between the first and second tape layers.In the case when other mechanisms such as zipper, buttons, or slidersare used, the tape may also be applied to provide the seal. In somecases, the perforation comprises a sliding dove-tail mechanism thatreleasably opens and closes the perforation.

The surgical drape 100 can be folded into a compact packet. The foldeddrape may be secured in an outer wrap or by adhesive tabs. The outerwrap or adhesive tabs may be removed when the packet is unfolded.

FIGS. 4A to 4C illustrate a method of using the surgical drape 100 witha patient 20 and a surgical system. As shown in steps A and B, thesurgical drape 100 may be unfolded toward the patient's head, and thefenestration 118 of the drape may be positioned over the operative areaof the patient. Next, the second portion 130 of the drape may be appliedover the patient's leg 24 as leggings. The second portion 130 may bewrapped around covering the legs 24 of the patient, as shown in step C.The second portion 130 may also cover a torso 22 of the patient.Proceeding to step D, the first portion of the drape 110 may be unfoldedto substantially cover an imaging probe (not shown) of the surgicalsystem, and the container portion 140 may be positioned in place belowthe surgical area. The first portion of the drape 110 provides lessphysical interference or impedance to the movement of the imaging probe.The visual transparency of the first portion of the drape 100 alsoallows an underlying site or tool to be viewed. The container portionmay 140 comprise attachment such as straps or tethers 150 for attachingthe container portion to the legs of the patient or to the operationtable, as described elsewhere herein. The straps help to hold thecontainer portion to a more stable support. As illustrated in step E,the tethers or straps 150 may comprise adhesive tabs to keep the tethersor straps folded and compacted when not in use. The tethers or strapsmay be extended and wrapped around the leggings of the surgical drapewhen in use. The tethers or straps 150 may be secured in place byplacing the adhesive taps on top of the strap or tether when not in use,as shown in step F. In some cases, the container portion may beconfigured to connect an exit port of the container portion to a suctionirrigation system to remove fluids from the container portion. Thesurgical drape 100 can be easily removed by separation along theperforation when a surgical process is finished.

Although FIGS. 4A to 4C illustrate a method of using a surgical drape inaccordance with some embodiments, a person of ordinary skill in the artwill recognize many adaptations and variations. For example, some of thesteps can be omitted, some of the steps replicated, and the steps can beperformed in any appropriate order.

FIG. 5 shows a surgical drape comprising one or more frame structures160, that may be combined with any embodiment disclosed herein. Theframe structures can be adapted to structurally maintain one or moreconfigurations of the surgical drape. For instance, the canopy portion111 may comprise one or more frame structures 160 to maintain or providethe working space/volume 114. The frame structures may be disposed inany location, or one or more portions of the drape. In some cases, theframe structures 160 may extend in an arc-like manner along sidewalls ofthe canopy portion 111, for example as shown in FIG. 5. In someembodiments, the frame structures may include a lining 161 along anopening of the container portion 140. The frame structures can be madeof any suitable materials such as metal, steel, plastic, fiber glass,and the like. In some cases, the frame structures can be folded andunfolded/deployed to support a variety of different configurations. Theframe structures may include or utilize spring steel or any other typeof elastic structure. In another example, the frame structures mayinclude or utilize compliant stiffening elements that are integratedinto the drape material. In some embodiments, at least one of the firstportion 110 or the second portion 130 of the surgical drape 100 may beoperably coupled to an actuation element (not shown). The actuationelement can be configured to deploy one or more sections of the surgicaldrape from a compact configuration to an extended configuration. Thecompact configuration may comprise a substantially two-dimensionalshape/profile, and the extended configuration may comprise asubstantially three-dimensional shape/profile. The surgical drape may bein the compact configuration when the drape is not in use. The surgicaldrape can be deployed to the extended configuration prior to or duringuse of the drape for the surgical treatment of the patient. The extendedconfiguration may correspond to a useable state/position for the drape.The actuation element may be integrated into the surgical drape, orincluded with the drape. In addition to deployment, the actuationelement can further provide structural reinforcement to one or moresections of the surgical drape (e.g. the canopy portion 111) in theextended configuration. Accordingly, the actuation element may compriseone or more stiffening elements. In some embodiments, the framestructures 160 shown in FIG. 5 may be the actuation element, or formpart of the actuation element.

The actuation element may comprise a stored energy device. The actuationelement may include one or more spring elements. Non-limiting examplesof spring elements can include a variety of suitable spring types, e.g.,nested compression springs, buckling columns, conical springs,variable-pitch springs, snap-rings, double torsion springs, wire forms,limited-travel extension springs, braided-wire springs, etc. Further,the actuation element (e.g., spring elements) can be made from any of anumber of metals (e.g. spring steel), plastics, or composite materials.In some cases, the actuation element may include fiberglass or plasticstiffeners, which also serve as stiffening elements as describedelsewhere herein.

In some cases, the one or more spring elements may include a deploymentspring positioned to deploy one or more sections of the surgical drapefrom the compact configuration to the extended configuration. Similarly,the one or more spring elements may include a retraction springpositioned to retract one or more sections of the surgical drape fromthe extended configuration back to the compact configuration. In someinstances, a monolithic spring can be configured to provide dualfunctions, e.g. (1) for deploying and also (2) for retracting one ormore sections of the surgical drape. For example, the monolithic springcan be configured to transform between two or more states (fullycompressed state, partially extended state, fully extended state, etc.).

In any of the embodiments disclosed herein, the actuation element caninclude magnets, electromagnets, pneumatic actuators, hydraulicactuators, motors (e.g. brushless motors, direct current (DC) brushmotors, rotational motors, servo motors, direct-drive rotational motors,DC torque motors, linear solenoids stepper motors, ultrasonic motors,geared motors, speed-reduced motors, or piggybacked motor combinations),gears, cams, linear drives, belts, pulleys, conveyors, and the like.

As described elsewhere herein, the first portion 110 of the surgicaldrape 100 may comprise an opening/aperture/fenestration 118. In someembodiments, the opening may include an elastic strap or an adjustableclosure that is configured to cinch around an organ of the patient asdescribed herein, for maintaining integrity of a sterile surgical fieldor environment. The adjustable closure may include, for example azipper. Additionally or optionally, the opening may include an adhesivematerial to gather and wrap loose sections of the drape around an organof the patient for maintaining integrity of a sterile surgical field orenvironment.

The first portion 110 of the surgical drape may comprise material forcovering the torso 22 or legs 24 of the patient, as described elsewhereherein.

Referring to FIG. 6, the material can be configured to hang loosely 602.The material can also be wrapped around 604 the torso or underside ofthe legs of the patient or stirrups. The material can be secured usingany means of attachment, for example straps, tethers, Velcro™, or tape.In some embodiments, the material may comprise an adhesive for attachingthe material around the stirrups to form a holder, in which a container140 for receiving and storing waste can be secured and suspended.

Referring to FIG. 7, the second portion 130 of the surgical drape can bemounted to a support structure 18. The support structure may compriseone or more arms. The support structure can be attached to an operatingtable over or near the patient. For example, the support structure canbe attached to bedrails 11 of an operating table. The second portion ofthe drape 130 can be mounted to the support structure, and similarly thesupport structure can be attached to the operating table using any meansof attachment, for example straps, tethers, Velcro™, or tape.

In any of the embodiments disclosed herein, the support structure 18 canbe coupled 19 to a graphical display (not shown). The display may besupported beneath the drape, or supported by the drape. The display maybe a screen. In some cases, the display may be a touchscreen. Thedisplay may include a light-emitting diode (LED) screen, OLED screen,liquid crystal display (LCD) screen, plasma screen, or any other type ofscreen. The display may be configured to show a user interface (UI) or agraphical user interface (GUI). The display can be operably coupled tothe imaging probe 12, articulating arm 14, and/or treatment probe 16. Aphysician may view real-time optical images collected by the imagingprobe 12 on the display. In some cases, a physician can control one ormore steps during the surgical treatment of the patient via the display(e.g. articulation of the treatment probe 16 and/or imaging probe 12 viathe arm 14).

The second portion 130 of the surgical drape may comprise a translucentor transparent material 138 that permits the graphical display to beviewed through the drape. The transparent material 138 may be providedin one or more regions of the drape, for example as shown in FIG. 7. Theone or more regions may include a translucent or transparent viewingwindow 139 such that the display can be viewed. In some embodiments, thegraphical display may include a touchscreen, and the translucentmaterial 138 may be compatible for use with the touchscreen such that auser (e.g. a physician) is able to interact with the touchscreen, withthe translucent material as an intervening layer. The graphical displaymay be located underneath the drape, but is visible through the viewingwindow 139 of the drape. In some embodiments, the translucent materialmay be flexible or loose-fitting so as to allow a user (e.g. physician)to manually manipulate one or more input/output (I/O) devices that areconnected to the graphical display. Examples of I/O devices can includea joystick, mouse, trackball, trackpad, 3-dimension cursor, button,knob, finger trigger, dials, touchscreen, touchpad, or keyboard. Thetranslucent material may include excess or extra material to accommodatea user's manipulation of one or more underlying I/O devices.

The container portion 140 (henceforth referred to as container) maycomprise a funnel shape to allow fluids to drain to an exit port 144.The container 140 may comprise a substantially conical funnel shape 156,for example as shown in FIG. 7. Alternatively, the container 140 maycomprise a substantially rectangular funnel shape 158, for example asshown in FIG. 8. In some embodiments, the container 140 may comprise abottom portion that is angled or sloped 147, for example as shown inFIG. 8. The angle or slope can be designed to enhance fluids flow totowards the exit port 144.

In some embodiments, the container may comprise structures forsupporting one or more configurations of the container. FIGS. 9A and 9Billustrate a container having a substantially rectangular funnel shapewith an angled or sloped bottom, in accordance with some embodiments.

The supporting structures can comprise interleaved structures, forexample vertical pleats 143 as shown in FIG. 9A, or horizontal pleats145 as shown in FIG. 9B. The vertical pleats 143 can serve or act asstiffeners that prevent the container 140 from collapsing and changingits shape/form when under load. Additionally or optionally, the verticalpleats 143 can be configured to allow airflow to vent displaced fluidsas the fluids is being extracted or drained from the container 140.Referring to FIG. 9B, the horizontal pleats 145 can permit the container140 to collapse into a collapsed or compact configuration in atelescoping manner. The container may be collapsible to a substantiallyplanar configuration, and extendable to a substantially 3-dimensionalconfiguration with aid of the horizontal pleats 145. The container 140may comprise one or more flexible, semi-rigid, or rigid materials. Thecontainer 140 can be designed to achieve various desired characteristicssuch as strength, rigidity, elasticity, compliance, and durability.Non-limiting examples of materials may include fabric, silicone,polyurethane, silicone-polyurethane copolymers, polymeric rubbers,polyolefin rubbers, hydrogels, semi-rigid and rigid materials,elastomers, rubbers, thermoplastic elastomers, thermoset elastomers,elastomeric composites, rigid polymers including polyphenylene,polyamide, polyimide, polyetherimide, polyethylene, epoxy, partiallyresorbable materials and the like.

In any of the embodiments disclosed herein, the container 140 can beconfigured to serve as a packaging enclosure for storing the surgicaldrape 100 or portion thereof. The packaging enclosure can be used tostore the surgical drape or portion thereof when the surgical drape isin its original state prior to use. Additionally or alternatively, thepackaging enclosure can be used to store the surgical drape or portionthereof for subsequent disposal after the surgical drape has been used.FIGS. 10A to 10D illustrate an embodiment in which the container 140 canbe used as a packaging enclosure 170 for storing the surgical drape 100.Referring to FIG. 10A, the drape 100 may be coupled to the container140, and may extend outside of the container. Prior to storing thedrape, the drape may be stretched out into a substantially planarconfiguration 172. Next, the drape may be folded in the manner as shownin FIG. 10B, by folding opposing ends 174-1 and 174-2 of the drapeinward relative to a longitudinal axis 175. Next, the drape may becompacted further by folding an end 176 inward relative to a transverseaxis 177, as shown in FIG. 10C. Finally, the drape can be folded andtucked into the container for storage as shown in FIG. 10D. The drapecan be stored in the container when new (i.e. prior to use of thedrape), and can be shipped in the container. Additionally or optionally,the drape can be stored in the container after the drape has been used(e.g. in a surgical treatment), for subsequent disposal ortransportation to a disposal facility. In some embodiments, thecontainer may include a lid (not shown) for covering the drape storedwithin the container.

In any of the embodiments disclosed herein, the container 140 can becoupled to and supported by a user, e.g. carried by a user 26, forexample as shown in FIG. 11. The user may be, for example a surgeon, andthe container can be coupled to the user in many ways, for example withstraps or tethers such that the user at least partially supports thecontainer. In the example of FIG. 11, the container may be coupled to ahalter 180 that is configured to be worn on or around the user's neck28, and the container may be supported by the halter around the user'sneck when in use, for example. In some instances (not shown), thecontainer may be coupled to a belt that that is configured to be wornaround the user's waist. In some embodiments, the container can bereleasably attached to a user's gown using one or more quick releasecouplings 154. The use of quick release couplings can help to improveoperating room efficiency, for example by facilitating portability ofcontainers and interchanging of used/new containers within the operatingroom. Examples of quick release couplings may include mechanicalcouplings, snapfits, adhesives, tapes, fasteners, magnets, and the like.The container may be releasably coupled to any portion of the user'sgown, in a manner that aids disposal of wastes and without impeding theuser's movement during the surgical treatment.

In any of the embodiments disclosed herein, the container 140 maycomprise one or more compliant stiffening elements for maintaining astructural form of the container. At least one of the first portion 110or the second portion 130 may comprise one or more frame structures thatsupport a configuration of at least the first portion or the secondportion. The compliant stiffening elements may be used as framestructures. For example, as shown in FIG. 12, stiffening elements 190may be provided as rib liners extending across various parts of thesurgical drape 100 and the container 140. Structural reinforcement canbe advantageous for prolonging the life of the container and thesurgical drape for multiple use/patient encounters. The structuralreinforcement can also be advantageous for fluid management, for exampleduring long surgeries involving significant fluid management formultiple use/patient encounters

In some cases, the container 140 may comprise structures for managementof fluid flow. The container 140 may comprise an integral perforatedtubing matrix 200 to maintain fluid flow and air displacement, forexample as shown in FIG. 13. The perforated tubing matrix 200 may beconnected to a drain/suction port located at a hole 142 or exit port 144of the container 140. The perforated tubing matrix may comprise one ormore tubes 202 serving as fluidic pathways or channels. The fluidicpathways or channels may be provided adjacent to the exit port 144 toprovide anti-block caused by prolapse drape. The tubes may be coupled toone another, and may intersect with one another. Each tube 202 maycomprise a plurality of perforations 204. The perforations may beprovided in a manner that aids in air displacement from the tubes andprevent clogging within the matrix. The fluidic channels may extend forany length along a plurality of surfaces of the drape 100 under a filterscreen. For example, a plurality of fluidic channels may extend forabout 5 cm to about 40 cm up the walls of the container 140 and underscreen 148. The container can be designed to ensure sufficient suctionof fluid 149 from the container by (1) providing non block-ablepassageways for the suction to act on the fluid, or (2) by providing amechanism that prevents material from folding over a vacuum port andblocking the vacuum port. In some alternative embodiments, the containermay comprise rolled up tube-like areas 210, for example as shown in FIG.14. The rolled up tube-like areas 210 may be formed from rolled up drapematerial, and may be connected to a drain/suction port to maintain fluidflow and air displacement, similar to the embodiment of FIG. 13.

In some cases, the container 140 may comprise a flap to prevent splashonto a user (e.g. a physician). FIG. 15 shows an example of container140 comprising a flap 220. In some cases, the flap may be deployable.The container may be configured having an inner sterile portion and anexternal non-sterile portion to protect the physician from splash. Theflap may comprise a non-sterile portion that extends outside of thesurgical drape. In some cases, the flap 220 may have a self-supportingsemi-cylindrical form. In some cases, one or more stiffening elements190 can be used to support a structural configuration of the containerand/or the flap. In some embodiments, one or more of the stiffeningelements 190 can be adjustable in position to prevent splash onto thephysician, for example by raising the flap higher.

The stiffening elements 190 can extend in directions transverse to eachother. For example, the stiffening elements 190 may extendcircumferentially and longitudinally along the container 140. Thestiffening elements may comprise a bendable material such as a thinwire, for example, or any stiffing structure or element as describedherein.

In some cases, the container 140 may comprise one or more ports 230 foraccepting fluid from an irrigation or aspiration pump, or from a drainline above or below a screen 148. FIG. 16 shows an example of the ports230 in accordance with some embodiments. The ports may comprise anopening, an aperture, a fenestration, a connecting feature, sealingflange, and the like.

In some embodiments, the container 140 may comprise one or more extrudedportions extending from the container 140. One or more of the extrudedportions may have a ‘tented’ shape. Referring to FIG. 17, the extrudedportions may help to define an inner sterile surface 242 and an externalnon-sterile surface 244. The external non-sterile surface 244 mayprovide a working space for placement of a support structure comprisingthe surgical arm (e.g. articulating arm 14). The external non-sterilesurface permits an ungloved hand to access a sterile space definedwithin the inner sterile surface 242 for manipulation of the transrectaldevice.

In some embodiments, the container may comprise a detachable screen 148,for example as shown in FIG. 18. The screen may be detachably coupled toan inner lower portion of the container 140. The screen may be detached252 from the container, and can be folded up 254 and sealed 256 forcollection and transportation of tissue or solid samples (for subsequentanalysis or disposal). The screen may comprise a hole that is sized orshaped to permit capture of clots or intact tissue. The screen maycomprise a material that is impervious to fluids, that is provided alongedges or sides of the screen. In some cases, the screen may comprise aclosure element for securing samples for storage or transport (thatenables the screen to be sealed 256). The closure element may comprise azipper, a zip-lock, an adhesive seal, a draw-string, a clip, or anelastic or conformable wire. In some cases, the screen may comprise atranslucent region that is compatible with imaging modalities for tissueanalysis. The screen may be removable from the container along the edgesor sides of the screen to permit visualization through the translucentregion. In some cases, the screen may comprise an area 258 fordisplaying information about the patient. The area 258 can be configuredto receive thereon a preprinted label containing the information aboutthe patient. Additionally or optionally, the area 258 can be configuredto permit a user to write thereon. In some cases, the area 258 maycomprise a plurality of sub-areas for displaying preprinted informationor clinician notes.

Referring to FIG. 19, the screen can be configured to fold with collapseof the container 240. The folding of the screen can be configured topermit airflow to a drain/suction port. The screen can be configured tofold in an interleaved manner.

Referring to FIG. 20, the canopy portion 111 may be designed such thatfluid is conducted to flow downwards 260 toward the container 140 whenthe canopy portion is in an inverted configuration. The invertedconfiguration can prevent fluids from accumulating or pooling on thecanopy portion 111 instead of flowing into the container 140. Theinverted configuration may comprise one or more sloping surfaces thataid the fluid to flow downward toward the container. The canopy portion111 may be shaped and/or sized 262 such that the canopy portion does notsag and collect fluids under weight of the fluids.

In some embodiments, the surgical drape 100 may comprise one or morelabels as described herein. The labels may comprise instructions forusing the drape, and information on one or more of the following: (a)location of one or more access port holes, (b) location of one or moreperforations, (c) location of one or more attachment points, (d) areasat which sections of the drape can be detached, (e) placement of thedrape onto the patient, (f) location of the drape relative to anoperating table, (g) attachment of the drape to the operating table, (h)location of the drape relative to one or more support structuresproximal to the operating table, or (i) attachment of the drape to theone or more support structures.

In some embodiments, the surgical drape 100 may comprise excess materialin at least the first portion 110 or the second portion 130 to permit anon-sterile hand of the user (e.g. a physician) from a non-sterileworking space outside of the drape to access and manipulate the probe 10comprising the transrectal device or the surgical arm 14 withoutcontaminating a sterile field underneath the drape. The canopy portion111 can be configured to permit the user to manipulate the surgical arm14 that supports the transrectal device.

FIG. 21 shows a surgical drape 100 comprising one or more labels. Thelabels may comprise a first label 550, a second label 552 and a thirdlabel 554, for example. Additional labels or fewer labels may beprovided with the drape 100. The labels may comprise any of the labelsas described herein. The labels may be affixed to the drape, so as toidentify structures of interest on the drape, such as access port holes,perforations, attachment points, areas of the drape that can be detachedas sections, placement of the drape on the patient, location of thedrape relative to the patient and the operating table, location of thedrape relative to support structures, and attachment of the drape tosupport structures. The one or more labels may comprise instructions foruse for the drape 100, and the instructions for use can be attached tothe drape or provided separately. The instructions for use can beaffixed to the drape on a sterile side of the drape, in order tomaintain sterility while one or more instructions is referred to by auser. The one or more instructions may comprise an arrow or otherindicia to identify portions of the drape that may be of interest to auser. For example, an arrow or a circle can identify the opening on thedrape through which a penis of the patient is passed from thenon-sterile side of the drape to the sterile side. One or moreperforations can be identified with an indicium associated with thelabel to identify the perforations.

FIG. 22A shows a method 300 of thermoforming the cover 100 as describedherein with a mold 310 and sheet material 320. The mold may comprisecontainer forming portion 312 comprising a curved surface, such as aconcave surface to contact sheet material 320, so as to define containerportion 140 of drape 100. The mold may comprise a canopy forming portion314 comprising a curved surface, such as a convex surface to contactsheet material 320. The canopy forming portion may comprise invertedportions comprising opposite curvature to facilitate drainage asdescribed herein, for example inverted portions adjacent, near, orwithin protrusion of canopy forming portion 314. The mold may comprisetorso forming portion 316, so as to define the torso portion of thedrape. The mold may comprise additional structures corresponding to apatient placed in stirrups for a urological procedure as describedherein, for example, structures corresponding to bent legs of a patient.

FIG. 22B shows a surgical drape 100 thermoformed over mold 310, so as todefine the three-dimensional shape profile of thermoformed surgicaldrape 330. Thermoformed surgical drape 330 may comprise any of thestructures of surgical drape 100 as described herein. For example, thethermoformed drape 330 may comprise container portion 140 as describedherein, first portion 110 comprising the canopy portion as describedherein, and second portion 130 comprising the torso portion as describedherein.

The thermoformed drape 330 may comprise one or more stiffing structuresas described herein, and the stiffening structures may comprisestiffening structures sandwiched between a plurality of layers ofthermoformed sheet material, for example. The stiffening structures canbe placed on a first thermoformed layer of the drape, and a second layerplaced over the stiffening structures so as to sandwich the stiffeningstructure between the layers, and the layers can bond together as partof the thermoforming process. Alternatively, or in combination,actuators can be sandwiched between thermoformed layers of the drape, soas to automatically expand and extend the drape from a compact packagedconfiguration for sterile storage to an expanded and extendedconfiguration for use on a patient. The sheet material may comprise anybiocompatible barrier material impermeable to bodily fluids, and can bethermoformed on the mold as will be understood by one of ordinary skillin the art.

The method 300 for thermoforming the drape 100 may comprise one or moresteps as follows: 1) receive sheet material to thermoform the mold; 2)manufacture the mold with the three-dimensional shape profile; place thesheet material on the mold; thermoform the sheet material to the shapeof the mold; place appropriate structures on the thermoformed sheet ofmaterial at appropriate positions and orientations, e.g. stiffeningstructures; thermoform a second sheet of material on the mold so as tobond the first sheet to the second sheet with the stiffening structurestherebetween; remove the thermoformed surgical drape 330 from mold 310;place the thermoformed surgical drape in a package or wrap thethermoformed drape within a packaging portion of the drape, in a compactstorage configuration; and sterilize the thermoformed drape.

Although method 300 of thermoforming a surgical drape is describedherein in accordance with an embodiment, a person of ordinary skill inthe art will recognize many variations and adaptations. Some of thesteps may be removed or repeated, and the steps may be performed in adifferent order, for example.

FIG. 23A shows a user manipulating a transrectal device through canopyportion 111 of surgical drape 100 and a corresponding first position 351of an engaged portion 352 of the proximal portion 350 of the transrectaldevice comprising probe 10 as described herein. The engaged portion ofthe transrectal device may comprise a portion of actuator 117 asdescribed herein, for example a knob of the actuator. The knob maycomprise of a portion of actuator 117 and may comprise an engagedportion 352 of the transrectal device. An engaged portion 354 of canopyportion 111 is located between the engaged portion 352 of the proximalportion 350 of the transrectal device, and an engaged portion 355 of thehand of a user such as a finger or thumb of the user. The engagedportion 355 of the hand of the user is coupled to the engaged portion354 of the canopy, with the engaged portion 354 of the canopy of thedrape located between the engaged portion 355 of the hand of the userand the engaged portion 352 of the proximal portion 350 of thetransrectal device. The coupling allows the canopy to move with the handand the canopy portion with a low resistance to movement, such that theproximal portion of the transrectal device appears to move freely withthe hand of the user with the proximal portion of the transrectal devicelocated within the canopy.

FIG. 23B shows the user manipulating the proximal portion 350 of thetransrectal device of FIG. 23A and a corresponding second position ofthe proximal portion of the transrectal device. The engaged portion 352of the proximal portion of the transrectal device has been moved to asecond position 353 with the engaged portion 355 of the hand of the userand the engaged portion 354 of the canopy portion 111. At the secondposition 353 the canopy has been moved from the first position 351 tothe second position 353 with a small substantially imperceptible aboutof force. The movement of the canopy typically provides a resistance tomovement that is less than the amount of force required to move theproximal portion 350 of the transrectal device. The amount of force tomove the engaged canopy portion can be less than one tenth ( 1/10), forexample less than one hundredth ( 1/100) of the amount of force used tomove the engaged portion 352 of the proximal portion of the transrectaldevice.

FIG. 23C shows return of the engaged portion 354 of the canopy portiontoward the first position 351 of the engaged portion as shown in FIG.23A. This return of the engaged portion of the canopy portion allows theuser to release proximal portion of the transrectal device and engagethe proximal portion of the transrectal device at a new location 356, soas to allow the user to move the proximal portion of the transrectaldevice again, while encountering substantially imperceptible amounts ofresistance from an engaged portion of the canopy as described herein.The amount of return can be a distance within a range from about 1 mm toabout 100 mm, for example within a range from about 1 mm to about 25 mm.

The proximal portion 350 of the transrectal device may comprise aproximal portion of any transrectal device as described herein. In someembodiments, the proximal portion of the transrectal device comprises aknob of the transrectal device that is coupled to a probe so as to allowmovement of the probe of the transrectal device. For example, the probeof the transrectal device can be mounted on a carriage coupled to theknob, such that the probe can be advanced distally and retractedproximally with rotation of the knob. In some embodiments, thetransrectal device comprises an ultrasound imaging probe as described inPCT Application PCT/US2013/028441, filed on Feb. 28, 2013, entitled“AUTOMATED IMAGE-GUIDED TISSUE RESECTION AND TREATMENT”, published asWO/2013/130895, the entire disclosure of which is incorporated herein byreference. A transrectal ultrasound image can be shown on a displayvisible to a user, such that the transrectal ultrasound probe can beadjusted through the canopy portion with return of the engaged canopyportion as described herein. The transrectal device may comprise aninput output (“I/O”) device as described herein so as to allow computercontrol of the position of the transrectal device, and the engagedportion of the canopy can return as described herein so as to facilitatemovement of the engaged portion of the hand of the user and interactionwith the I/O device.

The substantially imperceptible resistance to force provided by thecanopy portion 111 when the engaged portion 354 moves from the firstposition 351 to the second position 353 stores potential energy in thecanopy portion and in some embodiments additional portions of the drape100. This potential energy is released at least partially when theengaged portion 354 of the canopy 111 is released by the hand of theuser, and the engaged portion 354 returns from the second position 353toward the first position 351.

FIG. 24A shows a full volume of a canopy portion 111 in an extendedconfiguration. In the extended configuration, the sheets of the canopyhave been extended to substantially remove slack and folds. While thiscan be achieved in many ways, in some embodiments a lower perimeter ofthe canopy portion 111 can be supported and the canopy inflated with agas such as air to extend the canopy into the extended configuration todetermine a volume of the canopy. The canopy portion 111 may comprise alength L, a width W and a height H for embodiments in which the canopycomprises a rectangular protrusion. Each of these dimensions may bedefined by distances between corresponding corners of the canopyportions. The full volume of the canopy portion corresponds to thelength, width and height and may be calculated by the known formulas. Insome embodiments, the protruding canopy may comprise one or moresubstantially straight sides, and a comprise a partially trapezoidalshape, for example. In some embodiments the canopy portion comprises acurved surface sized and shaped to receive at least a proximal portionof the transrectal device. The curved surface when extendedsubstantially without slack or folds defines the volume of the canopyportion. The canopy portion 111 may comprise a combination ofsubstantially flat surface and curved surfaces, for example. In someembodiments, the lower perimeter of the canopy portion is supported andthe canopy portion inflated with a gas to expand the canopy portion tothe fully extended configuration in order to determine to the fullvolume. The amount of gas such as air within the fully expanded canopyportion can be measured by deflating the canopy portion to a fullydeflated and compact configuration and measuring the amount of gasreleased. The amount of gas released by be measured by any number ofways known to a person of ordinary skill in the art.

FIG. 24B shows a decreased volume of the canopy portion 111 of FIG. 24Ain a partially collapsed free standing configuration. The height H isdecreased in the free standing configuration, and the barrier sheetmaterial may comprise folds so as to decrease the height H by at leastabout 10%, for example. The length L and with width W defined bydistances between corners of the canopy may be similarly decreased, e.g.by at least about 10%. In some embodiments, the volume of the canopydecreases by an amount within a range from about 10% to 90% between thefully extended configuration and the partially collapsed free standingconfiguration. The canopy may comprise at least some weight, such thatthe volume of the canopy decreases in a partially collapsed freestanding configuration as compared with the volume of the canopy in thefully extended expanded configuration. The weight and stiffness of thebarrier material of the canopy can be configured to provide the partialcollapse of the canopy. A heavier (e.g. thicker) less stiff barriermaterial will collapse more than a lighter (e.g. thinner) barriermaterial comprising similar stiffness. A stiffer barrier material maycollapse less.

A lower perimeter of the canopy can be supported, and the volume of thepartially collapsed canopy determined, for example based on an amount ofgas released when the canopy is compressed from the free standingpartially collapsed configuration to the fully collapsed configuration.In some embodiments, the canopy barrier material inhibits the flow ofair from the canopy. The seals of the canopy, if present, may comprisesair tight seals to maintain the sterile field above the canopy. Thebarrier material of the canopy 111 may comprise a Young's modulus, athickness, and a density configured to provide the partial collapse ofthe canopy in the free-standing configuration as described herein.

The amount of return of the canopy portion as described herein can berelated to the Young's modulus, the thickness, the density of thebarrier material and the volume of the full volume of the canopy portionin relation to the amount of movement of the proximal portion of thetransrectal device. A person of ordinary skill in the art can determinesuitable configurations of materials as described herein to configurethe canopy with partial return during manipulation of the transrectaldevice, and partial collapse in the free standing configuration asdescribed herein.

FIG. 25A shows a surgical drape 100 coupled to an actuation element in acompact configuration in a side profile view.

FIG. 25B shows the surgical drape 100 of FIG. 25A in an extended profileconfiguration in a side profile view.

FIG. 25C shows the surgical drape of FIG. 25A in the compact profileconfiguration in a top profile view.

The surgical drape may comprise actuation elements in any and anylocation of the drape, so as to expand the drape from a compactconfiguration as described herein, e.g. as shown in FIG. 25A, to an atleast partially extended and at least partially expanded configurationas shown in FIG. 25C. The first portion 110 of the drape 100 comprisingcanopy portion 111 may comprise one or more actuation elements 410 inorder to at least partially extend and expand the canopy portion. Theactuation elements may comprise a shape memory material, such as springsteel or thermoformed plastic, configured to extend and expand thecanopy portion to an increased internal volume. In the compactconfiguration shown in FIG. 25C, the actuation elements may comprise abent configuration and straighten in the expanded profile configurationin FIG. 25B. The second portion 130 comprising the portion of drape 100configured to at least partially cover the torso of the patientcomprises actuation elements in some embodiments, either alternativelyor in combination with actuation elements 410 or one or more actionelements 420.

The container portion 140 of the drape may comprise one or moreactuation elements 420 configured to expand the container portion forman initial compact configuration to an expanded configuration to receivefluids as described herein.

Although the compact configuration of FIG. 25A is shown with the drapeextended along a length of the drape, actuation elements can be providedthat extend at least partially along the length of drape, so as to atleast partially unroll the drape to the configuration shown in FIG. 25A.For example, one or more actuation elements 420 can extend from thecontainer portion 140 through the first portion 110 comprising canopyportion 111 and at least partially along the second portion 130configured to at least partially cover the torso. The drape can beinitially provided in a rolled configuration in the sterile package,such that the drape unrolls in response to actuation elements 410 and420 to expand the drape from a compact configuration to the extendedprofile configuration as shown in FIG. 25B. Although reference is madeto a rolled configuration, the surgical drape 100 can be configured toexpand from a compact folded configuration to the extended profileconfiguration.

The surgical drape shown in FIGS. 25A to 25C can be configured withstiffening elements either alternatively to the actuation elements, orin combination with the stiffening elements. The stiffening elements maycomprise any stiffening element or structure as described herein and maycomprise metal extensions such as wire or pleats, for example. The metalextensions may comprise a deformable material, and a cross-sectionalthickness and length suitable for allowing the drape to be shaped asdesired by the user. The wire may comprise a suitable diameter to allowthe drape to be shaped to as desired by the user. The extensions can beplaced at one or more locations of the drape, such the canopy portion ofthe container portion, and combinations thereof.

The one or more actuation elements can be configured in many ways. Insome embodiments, the actuation element comprises one or more springelements, and optionally the one or more spring elements comprisesspring steel.

The container can be configured to receive, collect and store wasteincluding bodily fluids, surgical-related fluids, tissue or debrisgenerated during the surgical treatment. The container can be configuredto receive, collect and store waste including bodily fluids,surgical-related fluids, tissue or debris generated during the surgicaltreatment as described herein. In some embodiments, the containerportion 140 comprises a volume within a range from about 1000 cm³ toabout 70,000 cm³ in the expanded deployed configuration and optionallythe volume is within a range from about 1000 cm³ to about 10,000 cm³.

In some embodiments, at least one of a first portion comprising thecanopy portion or a second portion comprising the torso portion isoperably coupled to an actuation element configured to deploy one ormore sections of the surgical drape from a compact configuration to anextended configuration.

In some embodiments, the compact configuration comprises a substantiallytwo-dimensional shape, and the extended configuration comprises asubstantially three-dimensional shape.

In some embodiments, the surgical drape is in the compact configurationwhen the surgical drape is not in use prior to deployment, and deployedto the extended configuration prior to or during use of the surgicaldrape for the surgical treatment of the patient.

FIG. 26 shows an opening sized to receive a surgical urological probeand 132 perforations extending in a first direction corresponding toinferior and superior directions of a patent and perforations 450extending in second direction transverse to the first direction to allowthe surgical drape to be removed around a base 457 of a tensioningdevice coupled to a patient with a catheter extending along the urethraof the patient. Examples of a base and tensioning devices are describedin PCT application PCT/US2017/023062, filed on Mar. 17, 2017, entitled“MINIMALLY INVASIVE METHODS AND SYSTEMS FOR HEMOSTASIS IN A BLEEDINGCLOSED TISSUE VOLUME”, published as WO/2017/161331, the entiredisclosure of which is incorporated herein by reference. The base maycomprise a maximum dimension 454 across the base. The perforation 450extending in the second direction may extend a distance 452 greater thanmaximum dimension 454 across the base, so as to facilitate removal ofthe surgical drape when the base and tensioning device have been coupledto the patient. The maximum dimension across the base can be within arange from about 2.5 cm to about 30 cm, for example within a range fromabout 3 cm to about 20 cm. The distance 452 may comprise a distancewithin a range from about 2.5 cm to about 60 cm, for example within arange from about 3 cm to about 40 cm.

Although reference is made to perforations, the surgical drape can beconfigured in many ways similar to perforations 132 and 450. In someembodiments, a second portion comprising the torso portion comprises aweakened material extending a direction corresponding to a directionalong an inferior superior direction of the patent, e.g. along amidline. The second portion can be configured to assist removal of thesurgical drape by allowing the second portion to separate along theweakened material. In some embodiments, the weakened material comprisesone or more of perforations, thinned material relative to adjacentunweakened material, thermally or chemically weakened material orstressed material along the midline, or at any angle or offset to themidline, so as to extend a generally along a generally inferior orsuperior aspect of the patent. In some embodiments, a second weakenedmaterial extends in a second direction transverse to the midline inorder to facilitate removal of the surgical drape around a base of thetraction device coupled to the patient with a catheter extending along aurethra of the patient. The second weakened material extending in thesecond direction can be weakened similarly to the weakened materialextending in the first direction, and may comprise perforationsextending in the second direction, for example.

In some embodiments, the perforations allow insertion or access of acatheter to be inserted into a urethra of the patient. The catheter maycomprise a suprapubic catheter to drain urine from a bladder of thepatient, for example.

FIG. 27 shows a container portion 140 of a surgical drape 100 with aporous structure such as screen 148 upstream of a suction port 462. Theporous structure located upstream of suction port 462 may comprise anyporous structure as described herein, such as one or more of a tube withholes on an outer wall, a screen, a mesh, a fabric, a grating, aplurality of apertures formed in a sheet of material, an open cell foam,a sponge a screen, a perforated tubing matrix, fabric, a sinteredmaterial, or particles held together to define channels. The mesh maycomprise a fine mesh, for example. The porous structure such as screen148 can be located upstream of suction port and coupled to an inner wallof container portion 140 to direct fluid entering container portion 140through porous structure. The suction port can be connected to a sourceof suction, such as a surgical suction pump, with a tube coupled to thesuction port and the source of suction. The porous structure such asscreen 148 can filter particles comprising blood clots and ablatedtissue, to inhibit blockage of suction port 462. In some embodiments,the porous structure comprises channels having a maximum cross-sectionalsize no larger than a minimum inner cross-sectional size (e.g. minimumdiameter) of suction port 462, to ensure passage of clots or tissuepassed by the porous structure through the suction port. The porousstructure may comprise a surface area to receive surgical fluids, clotsand tissue.

The container portion 140 may comprise a fluid inlet 460 to receiveflowable material from a surgical procedure, such a surgical fluidcomprising tissue and clots from an ablation procedure. The ablation maycomprise a water jet ablation procedure performed with an ablation probeas described in in PCT Application No. PCT/US2013/028441, filed on Feb.28, 2013, entitled “AUTOMATED IMAGE-GUIDED TISSUE RESECTION ANDTREATMENT”, which has been previously incorporated by reference. Thefluid from the surgical probe can be coupled to the inlet with a tube,such that the ablated prostate tissue material can be collected on theporous structure and used for subsequent analysis.

In some embodiments, the receiving surface area of the porous structurecomprises a surface area greater than the minimum inner cross-sectionalsize of the suction port in order to provide additional channels of theporous structure to pass surgical fluids when solid material such asclots and tissue have been deposited on the porous structure.

The porous structure may comprise channels extending through a thicknessof the porous structure that are sized and shaped to collect tissue fromthe surgical procedure for subsequent analysis. The channels can besized no larger than the approximate size of a prostate cell, forexample no larger than about 5 microns (um). The channels of the porousstructure may comprise a maximum cross-sectional size within a rangefrom about 0.1 microns to about 5 microns, for example, in order tocapture individual cells of the prostate. Alternatively, the channels ofthe porous structure may comprise a larger cross-sectional size and maycomprise a maximum cross-sectional size within a range from about 5 umto about 1 mm in order to capture tissue of the prostate comprisingcells and blood clots received from inlet 460.

In some embodiments, the porous structure 148 and suction port 462 areconfigured such that an amount of fluid 464 accumulates in thecontainer. The porous structure can decrease the amount of fluidaccumulated in the container portion 140 as compared to fluidaccumulation without the porous structure. The surface area and the sizeof the channels of the porous structure can be configured to decreaseamount of fluid that accumulates between the porous structure and theopening to the suction port on an inner side of the container when thesuction port is coupled to the suction source. The amount of accumulatedfluid with the porous structure on the lower end of the container can bewithin a range from about 0.05 cm³ to about 500 cm³, for example withina range from about 0.05 cm³ to about 100 cm³. In some embodiments theporous structure can be separated from the suction port with a gapextending in between, and the amount of fluid that accumulates betweenthe porous structure and the opening to suction port can be withinsimilar ranges, e.g. from about 0.05 cm³ to about 100 cm³.

FIG. 28 shows a container 510 with a viewing window 514, in which thecontainer is sized to receive a porous structure such as screen 148 withmaterial from the patient supported thereon. The viewing window maycomprise an optically transparent material configured to allow viewingthe material from the patient with a high-resolution microscope forexample. The container 510 may comprise a sealed container that can besealed with the porous structure and material of the patient placedthereon. The container may comprise a barrier material configured toinhibit release of material from the patient.

FIG. 29 shows an image of surgical drape 100 used to conductexperimental testing. The inventors conducted several experiments todetermine the advantageous structures, elements and portions of thedrape and other elements as described herein. The surgical drape shownin FIG. 29 includes many of the elements and structures shown anddescribed above with reference to FIG. 1B. This testing was used todetermine appropriate shapes and structures and material properties ofthe drape to provide the beneficial functions and structures asdescribed herein, such as fluid management, stiffening structures anddimensions of the canopy and container, return of the canopy, and thedimensions and material properties of the porous structure, as describedherein.

As one of ordinary skill in the art will appreciate in view of thepresent disclosure, the surgical drape comprises a sterile side thatgenerally faces away from the patient and a non-sterile site thatgenerally faces toward the patient, in order to provide a sterilebarrier between the patient and the sterile side of the drape whenplaced on the patient. Alternatively or in combination, the surgicaldrape can be configured to cover the feet or legs of the patient, forexample with the second portion comprising the torso portion asdescribed herein extending so as to cover one or more of the feet orlegs of the patient.

In some embodiments the user of the drape places a handpiece down and/orresectoscope on top of the drape on the patient's stomach, and the drapemay comprise a fastener, such as a strap or Velcro or tether or tapeportion configured to allow the user to place the handpiece at locationsaway from or on the patient's stomach. Alternatively or in combination,the patient drape may comprise an adhesive material to adhesively coupleto the handpiece and/or resectoscope to limit movement of the surgicalinstrument. The adhesive can be covered with a peel or other material,such that the adhesive material is not exposed until the peel has beenremoved from the surface of the adhesive by the user such as a physicianor attendant. Securing the handpiece and/or resectoscope on the drapeabove the stomach can inhibit instruments from sliding down into thefluid container as described herein, which would be less than idealbecause the container may contain fluids and/or wrappers/gauze fromearlier in the surgical procedure.

In some embodiments, the surgical drape comprises fasteners such as oneor more of tape or Velcro section on one or more sides of the patient'slegs for wire and cable and tubing management, which can be used tobundle these together.

In some embodiments, the surgical drape as described herein comprises apackaging enclosure to store the surgical drape or portion thereof whenthe surgical drape comprises an initial compact configuration prior tobe expanded to the extended configuration, for example in its originalstate prior to use. The packaging portion may comprise an extension ofthe surgical drape configured to cover the drape in a compactconfiguration, for example with a lower non-sterile side of a portion ofthe drape folded so as to be exposed to a non-sterile exteriorenvironment. An internal sterile side of the folded portion of the drapecorresponding to the upper sterile side of the drape can be folded so asto a remainder of the drape, when the drape comprises the compactconfiguration prior to expansion to the extended configuration asdescribed herein.

Although reference is made to alternatives in the present disclosure,one or ordinary skill in the art will recognize that these alternativescan be combined in accordance with the teachings of the presentdisclosure.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

What is claimed is:
 1. A surgical drape for covering a patient and atransrectal device during a surgical treatment of the patient, the drapecomprising: a first portion comprising a canopy portion configured topermit a user to manipulate a transrectal device through the canopyportion, the canopy portion including one or more stiffening elementscoupled to a material of the canopy portion to maintain a working spaceunder the canopy portion, wherein the canopy portion comprises arectangular protrusion on an upper sterile side of the drape defining athree-dimensional space sized and shaped to cover a proximal portion ofthe transrectal device such that the proximal portion of the transrectaldevice is permitted to move within the three-dimensional space andwherein the transrectal device is configured to move within thethree-dimensional space in a non-restrictive manner; and a secondportion coupled to the first portion, the second portion comprising atorso portion sized and shaped to cover at least a portion of a torso ofthe patient; wherein the canopy portion and the torso portion comprise asterile barrier material and a fenestration formed through the sterilebarrier material of the first portion of the drape at a location that isbetween the canopy portion and the torso portion, wherein thefenestration is sized and shaped to receive a treatment probe throughthe fenestration and the barrier material and fenestration areconfigured to maintain sterility between a urethra and a rectum of thepatient when a sterile urological probe has been inserted into theurethra of the patient and a probe of the transrectal device has beeninserted into the rectum of the patient.
 2. The surgical drape of claim1, further comprising a container portion comprising sheet materialcoupled to the canopy portion to receive surgical fluids, the containerportion comprising a lower end with a suction port to drain fluids fromthe container portion and a porous structure upstream of the suctionport to inhibit clogging of the suction port.
 3. The surgical drape ofclaim 2, wherein the container portion comprises stiffeners to maintainthe container portion in an open configuration to receive the surgicalfluids and wherein the stiffeners comprise transversely extendingstiffeners.
 4. The surgical drape of claim 2, wherein the canopy portioncomprises inverted portions on the upper sterile side of the drape tofacilitate drainage toward the container portion.
 5. The surgical drapeof claim 2, wherein the torso portion, the canopy portion, and thecontainer portion comprise a material that is impervious to surgicalfluids.
 6. The surgical drape of claim 1, wherein the canopy portioncomprises an optically transmissive sterile barrier material thatpermits viewing of the proximal portion of the transrectal devicethrough the optically transmissive sterile barrier material.
 7. Thesurgical drape of claim 6, wherein the optically transmissive sterilebarrier material comprises one or more of a transparent material, atranslucent material, a semi-transparent material, or a semi-translucentmaterial.
 8. The surgical drape of claim 1, wherein the torso portioncomprises an opaque material and wherein the canopy portion comprises anopaque material.
 9. The surgical drape of claim 1, wherein thetransrectal device comprises one or more of a transrectalultrasonography (TRUS) probe or a colonoscope.
 10. The surgical drape ofclaim 1, wherein the canopy portion comprises a material having athickness ranging from about 0.05 mm to about 3 mm.
 11. The surgicaldrape of claim 10, wherein the material is substantially flexible. 12.The surgical drape of claim 1, wherein the treatment probe comprises oneor more of a surgical probe or a diagnostic probe.
 13. The surgicaldrape of claim 1, wherein the three-dimensional space defines a volumewithin a range from about 750 cm³ to about 70,000 cm³.
 14. The surgicaldrape of claim 1, wherein the three-dimensional space is sized andshaped to cover proximal portions of a plurality of transrectal devicesof different sizes and shapes.
 15. The surgical drape of claim 1,wherein the canopy portion comprises a volume that is greater than avolume occupied by the proximal portion of the transrectal device.